IU Vitamin D3 Research Articles

Effects of Vitamin D3 Supplementation and Resistance Training on 25-Hydroxyvitamin D Status and Functional Performance of Older Adults: A Randomized Placebo-Controlled Trial.

Vitamin D status is associated with muscle strength and performance in older adults. To examine the additive effects of vitamin D3 supplementation during resistance training, 100 seniors (65–85 years) participated in a 16-week intervention. Besides a daily dose of 400 mg of calcium, participants received either 800 IU vitamin D3 per day (VDD), 50,000 IU vitamin D3 per month (VDM) or nothing (CON). After the initial loading phase of four weeks, all groups started a 10-week resistance training program. Assessments of 25-hydroxyvitamin D (25(OH)D) status, muscle strength endurance (30-s chair stand and arm curl tests), aerobic capacity (6-min walk test) and functional mobility (gait speed and timed up and go test) were undertaken at baseline, after four weeks and at the end of the study. 25(OH)D status significantly improved in VDD and VDM, but not in CON (time x group: p = 0.021), as 15.2% of CON, 40.0% of VDD and 61.1% of VDM reached vitamin D sufficiency (>30 ng/mL; p = 0.004). Chair stand test, arm curl test, 6-min walk test, gait speed and timed up and go test improved over the whole intervention period (p < 0.05), however only chair stand and arm curl test were selectively affected by resistance training (p < 0.001). Neither muscle strength endurance, nor functional mobility or aerobic capacity were modulated by vitamin D supplementation. Therefore, the mere amelioration of 25(OH)D status of older adults does not lead to an additive effect on muscular performance during RT.

Effects of vitamin D3 injection in close-up period on insulin resistance and energy balance in transition dairy cows.

BackgroundMany studies in dairy cows are towards calcium homeostasis and there is a lack of knowledge about the effect of vitamin D in preventing insulin resistance and improving energy balance in the transition period of dairy cows.MethodsThe trial was conducted in a commercial dairy farm with about 1500 lactating cows in Tehran province, Iran. Twenty‐four Holstein cows had been randomly selected and divided into control and treatment groups. In the treatment group, 12 cows, received a single dose of 8,000,000 IU vitamin D3 intramuscularly and in the control group, 12 cows were injected placebo (distilled water) 2–8 days before the expected calving time. Blood samples were collected between 8 and 10 AM 2 h after feeding on 21 and 7 days before calving and 1,3,7,15 and 30 days after calving. 25(OH)vitamin D, insulin‐like growth factor 1 (IGF‐1), insulin, nonesterified fatty acid (NEFA), β‐hydroxybutyric acid (BHBA), albumin, total protein, glucose, urea, triglyceride, cholesterol and aspartate amino transferase (AST) were measured by commercially available kits. The insulin resistance index was calculated.ResultsVitamin D3 injection significantly affected the amounts of 25(OH) vitamin D, urea, insulin and insulin resistance index (p ≤ 0.05). On the other hand, the amounts of glucose, NEFA, BHBA concentration and AST activity were higher in control group (p ≤ 0.05). Time had a significant effect on the amounts of most measured variables except IGF‐1 and insulin. There were no group and time interactions for measured variables.ConclusionIt seems that injection of vitamin D3 in close up period influenced lipolysis potentially modifying energy metabolism and resulted in reducing insulin resistance.

Vitamin D metabolite and calcium phosphorus metabolism in in patients with primary hyperparathyroidism on the background of bolus therapy with colecalciferol

Vitamin D (25-hydroxyvitamin D [25(ОН)D]) deficiency (&lt;20 ng/mL) and insufficiency (20-29 ng/mL) are common in primary hyperparathyroidism (PHPT), but data regarding the vitamin D metabolism in this population is limited. The aim of this study is to estimate the vitamin D metabolites and their relationship with the main parameters of phosphorus-calcium metabolism in patients with PHPT at baseline and on the background of a single dose of cholecalciferol 150,000 IU. A single-center interventional, dynamic, prospective, comparative study has been carried out. The study included 54 participants, divided into two groups: the 1st group included 27 patients with confirmed PHPT, the2nd control group (n = 27), matched on gender (p = 0.062). The study included 4 visits; the baseline laboratory examination and a bolus dose of cholecalciferol were performed at the visit 1, the subsequent visits included a dynamic laboratory examination. Vitamin D deficiency (&lt;20 ng/ml) was detected in 69% of patients with PHPT. In the PHPT group (before cholecalciferol therapy), there was a direct association of 1.25(OH)2 D3 with albumin-corrected and ionized calcium, as well as between the 25(OH)D3 /24.25(OH)2 D3 ratio with PTH and magnesium. After taking of cholecalciferol, the levels of 1.25(OH)2 D3 and 25(OH)D3 /24.25(OH)2 D3 were significantly increased, and the levels of 25(OH)D3 /1.25(OH)2 D3 were significantly declined at all visits among patients with PHPT. The common 25(OH)D level was comparable to the control group, however the levels of 1,25(OH)2 D3 in patients with PHPT were 55% higher at baseline, and after taking of cholecalciferol 150,000 IU. They remained increased by 3-7 days by an additional 23-36%, significantly higher than those in the control group: 44%, 74%and 65%, at visits 2, 3 and 4, respectively (p&lt;0.05). The taking of 150,000 IU cholecalciferol in the PHPT group did not lead to asignificant increase in hypercalcemia and hypercalciuria, which indicates the safety of this dose in patients with mild hypercalcemia (albumin corrected calcium &lt;3 mmol/l). None of the study participants experienced any side effects. The completely comprehensive assessment of vitamin D metabolites was carried out for the first time inpatients with PHPT before and after using a bolus dose of cholecalciferol. The results confirmed the differences of vitaminD metabolism in chronic excessive secretion of PTH compared to control group, which is new data in the pathogenesis of thedisease, and can be used to develop optimal regimens for cholecalciferol taking in this population.

Should Vitamin D Supplements be Used as Adjunct Treatment for COVID-19: A Rapid Review

Background. Pooled data from observational studies suggest that patients with serum vitamin D levels below 30 ng/mL had an increased risk of infection and mortality from COVID-19. This rapid review aimed to determine the efficacy and safety of vitamin D as an adjunct treatment for COVID-19.&#x0D; Methods. We searched MEDLINE (PubMed) and CENTRAL up to July 18, 2021. We also searched trial registries, gray literature, and reference lists of included and excluded studies in the search as well as COVID-19 guidelines. Two reviewers independently screened titles and abstracts, collected data, and assessed for risk of bias. Meta-analysis was conducted, and an evidence profile table using GRADEpro was generated. Outcomes included were mortality, need for mechanical ventilator or progression of oxygen support, duration of mechanical ventilation, ICU admission, hospital length of stay, SARS-CoV-2 positivity at day 21, and adverse events.&#x0D; Results. We found four RCTs (3 low risk of bias and 1 high risk of bias). The sources of bias among the RCTs were unclear allocation, lack of blinding of patients, caregivers, and outcome assessors, and high drop-out rate. This rapid review found that the effects of vitamin D are inconclusive for the following outcomes: mortality (pooled RR 0.62, 95% CI [0.16 to 2.41], I2=49%; n=443, 3 RCTs, very low certainty of evidence), need for mechanical ventilator or progression of oxygen support (RR 0.52, 95% CI [0.24 to 1.13], n=237, 1 RCT, low certainty of evidence), and ICU admission (pooled RR 0.37, 95% CI [0.09 to 1.61], I2=78%; n=443, 3 RCTs, very low certainty of evidence. No significant reduction in hospital length of stay was found among those treated with vitamin D (MD 0 days, 95% CI [-1.19 to 1.09], low certainty of evidence). The duration of mechanical ventilation was also was also not significantly shortened in the treatment group (15 days) compared with placebo (12.8 days), MD 2.2 days, 95% CI [-8.4 to 12.8], low certainty of evidence. Interestingly, a higher proportion of those supplemented with vitamin D showed virologic clearance for COVID-19 on day 21 (RR 3.0, 95% CI [1.26 to 7.14], n=40, 1 RCT). At dosages between 60,000 to 200,000 IU of cholecalciferol, only one episode of vomiting (0.8%) was reported.&#x0D; Conclusion. Based on the evidence found, we are uncertain whether vitamin D is beneficial or harmful for patients with COVID-19. There is very low certainty of evidence to recommend the use of vitamin D supplements as an adjunct treatment for patients with COVID-19. Vitamin D supplementation for patients with COVID-19 should be limited to clinical trials or among those with proven vitamin D deficiency. More published studies are awaited to explore the benefit or harm of vitamin D for COVID-19.

Vitamin D related genetic polymorphisms affect serological response to high-dose vitamin D supplementation in multiple sclerosis

A poor 25-hydroxyvitamin D (25(OH)D) status is a much replicated risk factor for developing multiple sclerosis (MS), and several vitamin D-associated single nucleotide polymorphisms (SNPs) have been associated with a higher risk of MS. However, studies on the benefit of vitamin D supplementation in MS show inconclusive results. Here, we explore whether vitamin D-associated SNPs and MS risk alleles confound serological response to vitamin D supplementation. 34 participants from the SOLARIUM study consented to genotyping, of which 26 had vitamin D data available. The SOLARIUM study randomised relapsing-remitting MS patients to placebo or 14,000 IU vitamin D3 for 48 weeks. Participants were categorised as either 'carriers' or 'non-carriers' of the risk allele for 4 SNPs: two related to D binding protein (DBP) and associated with lower 25(OH)D levels (rs4588 and rs7041), and two related to vitamin D metabolism enzymes CYP27B1 and CYP24A1 and associated with a higher risk of MS (rs12368653; rs2248359, respectively). 25(OH)D levels were determined at baseline and after 48 weeks. The DBP-related SNPs showed no difference in 25(OH)D status at baseline, but carriers of the rs7041 risk allele showed lower 25(OH)D-levels compared to non-carriers after 48 weeks of supplementation (median 224.2 vs. 332.0 nmol/L, p = 0.013). For CYP related SNPs, neither showed a difference at baseline, but carriers of the rs12368653 risk allele showed higher 25(OH)D-levels compared to non-carriers after 48 weeks of supplementation (median 304.1 vs. 152.0 nmol/L, p = 0.014). Vitamin D-related SNPs affect the serological response to high-dose vitamin D supplementation. The effects on more common doses of vitamin D, as well as the clinical consequence of this altered response, need to be investigated further.

Assessment of Vitamin D Metabolism in Patients with Cushing’s Disease in Response to 150,000 IU Cholecalciferol Treatment

In this study we aimed to assess vitamin D metabolism in patients with Cushing’s disease (CD) compared to healthy individuals in the setting of bolus cholecalciferol treatment. The study group included 30 adults with active CD and the control group included 30 apparently healthy adults with similar age, sex and BMI. All participants received a single dose (150,000 IU) of cholecalciferol aqueous solution orally. Laboratory assessments including serum vitamin D metabolites (25(OH)D3, 25(OH)D2, 1,25(OH)2D3, 3-epi-25(OH)D3 and 24,25(OH)2D3), free 25(OH)D, vitamin D-binding protein (DBP) and parathyroid hormone (PTH) as well as serum and urine biochemical parameters were performed before the intake and on Days 1, 3 and 7 after the administration. All data were analyzed with non-parametric statistics. Patients with CD had similar to healthy controls 25(OH)D3 levels (p > 0.05) and higher 25(OH)D3/24,25(OH)2D3 ratios (p < 0.05) throughout the study. They also had lower baseline free 25(OH)D levels (p < 0.05) despite similar DBP levels (p > 0.05) and lower albumin levels (p < 0.05); 24-h urinary free cortisol showed significant correlation with baseline 25(OH)D3/24,25(OH)2D3 ratio (r = 0.36, p < 0.05). The increase in 25(OH)D3 after cholecalciferol intake was similar in obese and non-obese states and lacked correlation with BMI (p > 0.05) among patients with CD, as opposed to the control group. Overall, patients with CD have a consistently higher 25(OH)D3/24,25(OH)2D3 ratio, which is indicative of a decrease in 24-hydroxylase activity. This altered activity of the principal vitamin D catabolism might influence the effectiveness of cholecalciferol treatment. The observed difference in baseline free 25(OH)D levels is not entirely clear and requires further study.

Effect of Calcium and Vitamin D Supplementation With and Without Collagen Peptides on Volumetric and Areal Bone Mineral Density, Bone Geometry and Bone Turnover in Postmenopausal Women With Osteopenia

Collagen peptides (CPs) have been shown to potentially have a role as a treatment option in osteopenia. In the present randomized prospective study, we examined the effect of calcium, vitamin D with and without CPs supplementation on changes in volumetric bone mineral density (vBMD) and bone geometry assessed by peripheral quantitative computed tomography at the tibia, areal bone mineral density (aBMD) assessed by dual-energy X-ray absorptiometry at the lumbar spine and the hip and bone turnover markers over 12-mo. Fifty-one postmenopausal women with osteopenia were allocated to Group A who received orally 5 g CPs, 500 mg calcium and 400 IU vitamin D3 and Group B who received the same dose of calcium and vitamin D3 per day. The primary endpoint was the change of trabecular bone mineral content (BMC) and vBMD after 12-mo supplementation in Groups A and B. At the trabecular site (4% of the tibia length), Group A had a significant increase of total BMC by 1.96 ± 2.41% and cross-sectional area by 2.58 ± 3.91%, trabecular BMC by 5.24 ± 6.48%, cross-sectional area by 2.58 ± 3.91% and vBMD by 2.54 ± 3.43% and a higher % change of these parameters at 12 mo in comparison to Group B (p < 0.01, p = 0.04, p < 0.01, p = 0.04, p = 0.02, respectively). At the cortical site (38% of the tibia length), total and cortical vBMD increased by 1.01 ± 2.57% and 0.67 ± 1.71%. Furthermore, the mean aBMD at the spine was higher (p = 0.01), while bone markers decreased in Group A compared to Group B. The present study shows improvement of trabecular and cortical parameters as assessed by peripheral quantitative computed tomography at the tibia, prevention of aBMD decline and decrease of bone turnover after 12-mo supplementation with calcium, vitamin D with CPs.

The effects of vitamin D supplemantation on prognosis in patients with mild obstructive sleep apnea syndrome

The aim of this study was to investigate the effect of vitamin D on the disease prognosis and biochemical parameters in patients with mild obstructive sleep apnea syndrome (OSAS). Nineteen adult male individuals (18–65 years) who were diagnosed with mild OSAS after polysomnography and had low vitamin D levels were included in the study. Each week, patients took 50.000 IU Vitamin D3 supplementation for 8 weeks. Polysomnography, biochemical parameters FBG (fasting blood glucose), lipid profile (TG, TC, LDL-C, HDL-C, VLDL-C), calcium, phosphorus, parathormone, calcitonin, serum 25(OH)D, insulin, CRP, TNF-α, IL-6, and IL-10 of patients were evaluated at the beginning of study and at the end of the study. All assessments, including polysomnography, were repeated after 8 weeks. Serum vitamin D levels were initially 19.5 ± 5.01 ng/mL and increased to 41.8 ± 10.51 ng/mL (p < 0.001) at the end of the study. FBG, TC and HOMA-IR of the patients were significantly decreased (p < 0.05). CRP, TNF-α, IL-6, and IL-10 levels were also correlated with serum vitamin D levels (p < 0.05). There was a significant decrease in number of obstructive apneas, apneas a nd hypopneas, apnea index, hypopnea index, and apnea hypopnea index of the patients (p < 0.05). As a result, it is thought that vitamin D supplementation may have a positive effect on the disease prognosis of mild OSAS.

Effects of Monthly Intramuscular High-Dose Vitamin D2 on Serum 25-Hydroxyvitamin D and Immune Parameters in Very Elderly Chinese Patients with Vitamin D Deficiency.

Purpose Vitamin D deficiency is highly prevalent among the very elderly and is associated with a wide variety of clinical conditions other than musculoskeletal diseases. This study aims to ascertain the efficacy and safety of high-dose intramuscular vitamin D2 in very elderly Chinese patients with vitamin D deficiency. Methods Very elderly (aged 80 years or over) Chinese patients with vitamin D deficiency were recruited to receive monthly intramuscular injections of 600,000 IU vitamin D2 until their serum 25-hydroxyvitamin D (25(OH)D) reached ≥30 ng/mL. The serum levels of 25(OH)D2, 25(OH)D3, iPTH, BTMs, immune parameters, and other biochemical parameters were measured at baseline and one month after each dose. Results Of the 30 very elderly Chinese patients who had been recruited into the study, 27 (90.0%) had their vitamin D deficiency corrected, and 26 (86.7%) reached vitamin D sufficiency. The mean time (±SD) was 3.1 (±1.3) months for vitamin D deficiency to be corrected, and 6.1 (±0.8) months for vitamin D sufficiency to be reached. The mean (±SD) serum level of 25(OH)D2 increased from 0.69 (±1.51) ng/mL to 29.07 (±5.68) ng/mL, while the mean (±SD) serum level of 25(OH)D3 decreased from 9.82 (±2.75) ng/mL to 5.30 (±3.09) ng/mL (both P < 0.001). The total T cells in serum remained unchanged (P > 0.05), and the CD4 and B cells (CD19+) were increased significantly (both P < 0.05). In addition, no significant change was observed in the serum levels of iPTH and BTMs. Conclusion Monthly intramuscular injection of 600,000 IU vitamin D2 is an effective and safe dosing regimen to reach vitamin D sufficiency and enhances immune function in the very elderly Chinese patients with vitamin D deficiency.

Vitamin D Supplementation Improves Fasting Insulin Levels and HDL Cholesterol in Infertile Men

Vitamin D has been linked with glucose and lipid metabolism. Men with impaired gonadal function have a higher risk of metabolic syndrome and mortality, and vitamin D status may be a reversible modulator. This work aimed to determine the effect of daily vitamin D and calcium supplementation for 150 days on glucose and lipid homeostasis in infertile men. A single-center, double-blinded, randomized clinical trial (NCT01304927) was conducted. A total of 307 infertile men were randomly assigned (1:1) to a single dose of 300 000 IU cholecalciferol followed by 1400 IU cholecalciferol + 500 mg of calcium daily (n = 151) or placebo (n = 156) for 150 days. Reported metabolic parameters including fasting plasma glucose, glycated hemoglobin A1c, fasting serum insulin, homeostatic model assessment of insulin resistance (HOMA-IR), fasting plasma cholesterols, and triglycerides were secondary end points. The primary end point semen quality has previously been reported. Men receiving vitamin D supplementation improved their vitamin D status, whereas vitamin D status was aggravated in the placebo group characterized by higher serum parathyroid hormone. At the end of the trial, men receiving vitamin D supplementation had 13% lower fasting serum insulin concentrations compared with the placebo-treated group (65 vs 74 pmol/L, P = .018) and 19% lower HOMA-IR (2.2 vs 2.7, P = .025). Moreover, men in the vitamin D group had higher high-density lipoprotein (HDL) cholesterol levels (1.38 vs 1.32 mmol/L, P = .008) compared with the placebo group. High-dose vitamin D supplementation has beneficial effects on glucose homeostasis and HDL cholesterol levels in infertile men.

Elastic resistance training is more effective than vitamin D3 supplementation in reducing oxidative stress and strengthen antioxidant enzymes in healthy men.

ObjectiveToday, reducing oxidative stress and improving the antioxidant system with antioxidant supplements along with exercise training has received a lot of attention. Vitamin D plays a very important role in general health and reducing oxidative stress. The aim of this study was to examine the effect of vitamin D3 supplements during elastic-band resistance training (EBT) on oxidative stress and antioxidant indices in healthy men.MethodsForty healthy men (Serum: 20 ≤ 25 (OH) D ≤ 25 ng/mL) voluntarily participated in the current study and randomly were assigned to EBT-vitamin D3 (ED, n = 10), EBT-placebo (EP, n = 10), vitamin D3 (VD, n = 10), and control (Con, n = 10). EBT was performed three times per week on non-consecutive days for eight weeks, in seven exercises. The subjects in the ED, VD, and EP consumed 50,000 IU vitamin D3 or placebo once every 2 weeks. Ten ccs blood samples were collected before and after exercise training and the total antioxidant capacity (TAC), superoxide dismutase (SOD), glutathione peroxidase (GPX), and creatine kinase (CK) activities were measured in the plasma. Malondialdehyde (MDA), as the lipid peroxidation index, and 25(OH) D were measured in the plasma.ResultsWe found that there was a significant difference between ED with VD (p = 0.011) and Con (p = 0.022) for MDA. A significant difference was also seen for SOD in ED with VD (p = 0.024) and Con (p = 0.038) and TAC in ED with VD (p = 0.020) and Con (p = 0.030), and GPX in ED with VD (p = 0.040) and Con (p = 0.010). While there were no significant differences between ED and EP in all mentioned variables (p > 0.05).ConclusionFinally, it can be said that elastic resistance training improved antioxidant defence. However, vitamin D3 supplementation during resistance elastic training has no synergistic effect on attenuating oxidative stress indices.

The effect of cholecalciferol supplementation on allograft function in incident kidney transplant recipients: A randomized controlled study

It is unknown whether cholecalciferol supplementation improves allograft outcomes in kidney transplant recipients (KTRs). We conducted a single‐center randomized, double‐blind, placebo‐controlled trial of daily 4000 IU cholecalciferol supplementation in KTRs at 1‐month posttransplant. The primary endpoint was the change in eGFR from baseline to 12‐month posttransplant. Secondary endpoints included severity of interstitial fibrosis and tubular atrophy (IFTA) at 12‐month posttransplant and changes in urinary biomarkers. Of 193 randomized patients, 180 participants completed the study. Changes in eGFR were 1.2 mL/min/1.73 m2 (95% CI; −0.7 to 3.1) in the cholecalciferol group and 1.8 mL/min/1.73 m2 (95% CI, −0.02 to 3.7) in the placebo group, with no significant between‐group difference (−0.7 mL/min/1.73 m2 [95% CI; −3.3 to 2.0], p = 0.63). Subgroup analyses showed detrimental effects of cholecalciferol in patients with eGFR <45 mL/min/1.73 m2 (Pinteraction <0.05, between‐group difference; −4.3 mL/min/1.73 m2 [95% CI; −7.3 to −1.3]). The degree of IFTA, changes in urine albumin‐to‐creatinine ratio, or adverse events including hypercalcemia and infections requiring hospitalization did not differ between groups. In conclusion, cholecalciferol supplementation did not affect eGFR change compared to placebo among incident KTRs. These findings do not support cholecalciferol supplementation for improving allograft function in incident KTRs.Clinical trial registry: This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN‐CTR) as UMIN000020597 (please refer to the links below). UMIN‐CTR: https://upload.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view.cgi?recptno=R000023776

A 16-week randomized controlled trial of a fish oil and whey protein-derived supplement to improve physical performance in older adults losing autonomy-A pilot study.

Low functional capacity may lead to the loss of independence and institutionalization of older adults. A nutritional intervention within a rehabilitation program may attenuate loss of muscle function in this understudied population. This pilot study assessed the feasibility for a larger RCT of a nutritional supplementation in older adults referred to an outpatient assessment and rehabilitation program. Participants were randomized to receive a supplement (EXP: 2g fish oil with 1500 IU vitamin D3 1x/d + 20-30g whey protein powder with 3g leucine 2x/d) or isocaloric placebo (CTR: corn oil + maltodextrin powder) for 16 weeks. Handgrip and knee extension strength (using dynamometry), physical performance tests and plasma phospholipid n-3 fatty acids (using GCMS) were evaluated at weeks 0, 8 and 16; and lean soft tissue mass (using DXA), at weeks 0 and 16. Over 2 years, 244 patients were screened, 46 were eligible (18.9%), 20 were randomized, 10 completed the study (6 CTR, 4 EXP). Median age was 87 y (77-94 y; 75% women) and gait speed was 0.69 m/s; 55% had low strength, and all performed under 420m on the 6-minute walk test, at baseline. Overall self-reported compliance to powder and oil was high (96% and 85%) but declined at 16 weeks for fish oil (55%). The EXP median protein intake surpassed the target 1.2-1.5 g/kg/d, without altering usual diet. Proportions of plasma phospholipid EPA and DHA increased significantly 3- and 1.5-fold respectively, at week 8 in EXP, with no change in CTR. Participants were able to complete most assessments with sustained guidance. Because of low eligibility, the pilot study was interrupted and deemed non-feasible; adherence to rigorous study assessments and to supplements was adequate except for long-term fish oil. The non-amended protocol may be applied to populations with greater functional capacity. ClinicalTrials.gov NCT04454359.

The effect of high-dose parenteral vitamin D3 on COVID-19-related inhospital mortality in critical COVID-19 patients during intensive care unit admission: an observational cohort study.

BackgroundIn many studies, vitamin D has been found to be low in COVID-19 patients. In this study, we aimed to investigate the relationship between clinical course and inhospital mortality with parenteral administration of high-dose vitamin D3 within the first 24 h of admission to patients who were hospitalized in the intensive care unit (ICU) because of COVID-19 with vitamin D deficiency.MethodsThis study included 175 COVID-19 patients with vitamin D deficiency [25(OH) D <12 ng/mL] who were hospitalized in the ICU. Vitamin D3 group (n = 113) included patients who received a single dose of 300,000 IU vitamin D3 intramuscularly. Vitamin D3 was not administered to the control group (n = 62).ResultsMedian C-reactive protein level was 10.8 mg/dL in the vitamin D3 group and 10.6 mg/dL in the control group (p = 0.465). Thirty-nine percent (n = 44) of the patients in the vitamin D3 group were intubated endotracheally, and 50% (n = 31) of the patients in the control group were intubated endotracheally (p = 0.157). Parenteral vitamin D3 administration was not associated with inhospital mortality by multivariate logistic regression analysis. According to Kaplan–Meier survival analysis, the median survival time was 16 d in the vitamin D3 group and 17 d in the control group (log-rank test, p = 0.459).ConclusionIn this study, which was performed for the first time in the literature, it was observed that high-dose parenteral vitamin D3 administration in critical COVID-19 patients with vitamin D deficiency during admission to the ICU did not reduce the need for intubation, length of hospital stay, and inhospital mortality.

Efficacy of Daily Supplementation of Milk Fortified With Vitamin D2 for Three Months in Healthy School Children: A Randomized Placebo Controlled Trial

To evaluate the efficacy of daily supplementation of 200 mL milk fortified with 240 IU of vitamin D2 (ergocalciferol). Double-blind randomized controlled trial. School-based study in Delhi between October and December, 2019. 235 healthy children aged 10-14 years. Daily supplementation of 200 mL milk fortified with 240 IU of ergocalciferol in intervention group (n=119) and 200 mL of plain milk in control group (n =116) for 3 months. Change in serum 25 hydroxy vitamin D (25(OH)D), parathyroid hormone (PTH), bone formation and resorption markers, and urinary calcium creatinine ratio (U-Ca/CrR). The mean (SD) baseline serum 25(OH) D level in control and fortification groups was 11.9 (3.8) and 11.4 (3.6) ng/mL (P=0.23), respectively. The serum 25(OH)D levels did not increase post-intervention with the dose used for fortification, but were significantly higher in intervention group as compared to control group [10.8 (3.4) vs 6.7 (3.5) ng/mL; P<0.001]. A higher proportion of secondary hyperparathyroidism was observed post-intervention in control (39%) than in intervention group (13.3%); P<0.001. Serum carboxy-terminal telopeptide levels were similar in both groups but the serum procollagen type1 N-terminal propeptide levels were higher in the control than intervention group (P<0.007), following supplementation. Supplementation of milk fortified with approximately 240 IU vitamin D2 for three months did not achieve sufficient serum 25(OH)D levels in Indian children with vitamin D deficiency during winter.

Vitamin D Perspective in Front Line Healthcare Workers Amid COVID-19

Deficiency of Vitamin D is very common in Pakistan, even among healthy asymptomatic individuals [1], [2]. Recent studies have shown that the risk of contracting COVID-19 was increased to two-fold, and consequent mortality to 4-fold if the person is Vitamin D deficient [3]. Health care workers including the nursing and administration staff are at a high risk of contracting SARS-CoV2 due to increased regular exposure in a health care setting [4]. Consequently, a convergence of the COVID-19 pandemic, the deficiency of Vitamin D, and the increased exposure can render the health care workers at an additional risk to COVID-19 infection. Our objective was to determine the prevalence of vitamin D deficiency in healthy asymptomatic front-line health care workers and to analyze the change in serum level by loading oral dose of SunnyD STAT softgel capsules (200000 IU Vitamin D3). We followed single centered, cross-sectional, cohort study with subsequent randomized placebo-controlled design for supplementation and follow up. Serum level of 25-hydroxyvitamin D (25OHD) was the main outcome variable, with anthropometric data, nutritional intake, and lifestyle variables analyzed for potential association as risk factors for the outcome. Severe Vitamin D deficiency was found to be prevalent among front line health care workers in this urban hospital-based sample. Serum level of Vitamin D was found to be significantly associated with designation and presence of high blood pressure. The likelihood of increased serum Vitamin D levels was observed with increasing monthly income, higher designation, increasing age and supplementation intake. Mean increase in the serum 25(OH)D3 level after 2 doses of SunnyD STAT softgel capsule (200000 IU Vitamin D3) was 34.22 ng/ml. Public health interventions regarding Vitamin D supplementation and awareness are needed, especially amid COVID-19 pandemicDeficiency of Vitamin D is very common in Pakistan, even among healthy asymptomatic individuals [1], [2]. Recent studies have shown that the risk of contracting COVID-19 was increased to two-fold, and consequent mortality to 4-fold if the person is Vitamin D deficient [3]. Health care workers including the nursing and administration staff are at a high risk of contracting SARS-CoV2 due to increased regular exposure in a health care setting [4]. Consequently, a convergence of the COVID-19 pandemic, the deficiency of Vitamin D, and the increased exposure can render the health care workers at an additional risk to COVID-19 infection. Our objective was to determine the prevalence of vitamin D deficiency in healthy asymptomatic front-line health care workers and to analyze the change in serum level by loading oral dose of SunnyD STAT softgel capsules (200000 IU Vitamin D3). We followed single centered, cross-sectional, cohort study with subsequent randomized placebo-controlled design for supplementation and follow up. Serum level of 25-hydroxyvitamin D (25OHD) was the main outcome variable, with anthropometric data, nutritional intake, and lifestyle variables analyzed for potential association as risk factors for the outcome. Severe Vitamin D deficiency was found to be prevalent among front line health care workers in this urban hospital-based sample. Serum level of Vitamin D was found to be significantly associated with designation and presence of high blood pressure. The likelihood of increased serum Vitamin D levels was observed with increasing monthly income, higher designation, increasing age and supplementation intake. Mean increase in the serum 25(OH)D3 level after 2 doses of SunnyD STAT softgel capsule (200000 IU Vitamin D3) was 34.22 ng/ml. Public health interventions regarding Vitamin D supplementation and awareness are needed, especially amid COVID-19 pandemic.

The Effects of Cholecalciferol Supplementation on FGF23 and α-Klotho in Hemodialysis Patients With Hypovitaminosis D: A Randomized, Double-Blind, Placebo-Controlled Trial

Vitamin D-fibroblast growth factor-23 (FGF-23)-klotho forms an axis that takes part at least in cardiovascular complications in patients with chronic kidney disease. This study aimed to assess the effects of cholecalciferol supplementation on FGF23 and α-klotho in patients with hypovitaminosis D requiring hemodialysis. In a single-center, parallel-arm, randomized, double-blind, placebo-controlled trial, 86 patients with hypovitaminosis D requiring hemodialysis were enrolled. The patients were randomized into 2 groups (n=43 each) to receive either 50,000 IU of cholecalciferol or placebo every week for 12weeks. Accordingly, the serum levels of FGF23 and klotho were measured by ELISA and compared between both groups. Serum 25OH(D) levels increased in participants who received cholecalciferol supplementation compared with participants who received placebo (P=.006). In addition, serum FGF23 decreased and α-klotho levels increased in the supplemented group compared with placebo. However, the before-after differences between cholecalciferol supplement and placebo were significant only for α-klotho (P=.035). These effects were not accompanied by changes in the levels of phosphate, total and ionized calcium, and intact parathyroid hormone. Cholecalciferol supplementation of 50,000 IU for 12weeks increases α-klotho levels in the serum of kidney failure patients undergoing hemodialysis. This may suggest that patients receiving maintenance hemodialysis can benefit from using cholecalciferol supplementation and increase in serum α-klotho levels.

Impact of Maternal Daily Oral Low-Dose Vitamin A Supplementation on the Mother-Infant Pair: A Randomised Placebo-Controlled Trial in China.

Background: The nutritional status of vitamin A in lactating mothers and infants is still not optimistic. Due to the dietary habits and dietary restrictions of postpartum customs in China, vitamin A supplementation has been advocated as a potential strategy to improve vitamin A status of lactating mothers with inadequate dietary vitamin A intake. Existing clinical trials are limited to single or double high-dose maternal administrations. However, in China, vitamin A supplements are readily available in the form of daily oral low-dose supplements, and the effect of these is unknown. This study aimed to evaluate the effects of daily oral low-dose vitamin A supplementation on the retinol levels in the serum and breast milk of lactating mothers and the health status of infants in China. Methods: Lactating mothers who met the inclusion criteria and planned to continue exclusive breastfeeding were randomly assigned to receive either daily oral vitamin A and D drops (one soft capsule of 1800 IU vitamin A and 600 IU vitamin D2), or a matching placebo for 2 months. Before and after the intervention, dietary intake was investigated by instant photography, and the retinol concentration in maternal serum and breast milk was determined by ultra-high performance liquid chromatography-tandem mass spectrometry. During the trial, the health status of infants was diagnosed by a paediatrician or reported by lactating mothers. A total of 245 participants completed the study, with 117 in the supplementation group and 128 in the control group. Results: After the 2-month intervention, maternal serum retinol concentrations increased in the supplementation group with no change in the control group. Although breast milk retinol concentrations decreased significantly in both groups, the decrease in the supplementation group was significantly lower than that in the control group. However, maternal vitamin A supplementation was not associated with a lower risk of infant febrile illness, respiratory tract infection, diarrhoea, and eczema. Conclusions: Daily oral low-dose vitamin A supplementation is helpful in improving maternal vitamin A status, despite having no effect on infant health status through breast milk.

Effects of a 2-Week 5000 IU versus 1000 IU Vitamin D3 Supplementation on Recovery of Symptoms in Patients with Mild to Moderate Covid-19: A Randomized Clinical Trial.

Objective: Vitamin D deficiency has been associated with an increased risk of COVID-19 severity. This multi-center randomized clinical trial aims to determine the effects of 5000 IU versus 1000 IU daily oral vitamin D3 supplementation in the recovery of symptoms and other clinical parameters among mild to moderate COVID-19 patients with sub-optimal vitamin D status. Study Design and Setting: A total of 69 reverse transcriptase polymerase chain reaction (RT-PCR) SARS-CoV-2 positive adults who were hospitalized for mild to moderate COVID-19 disease were allocated to receive once daily for 2 weeks either 5000 IU oral vitamin D3 (n = 36, 21 males; 15 females) or 1000 IU oral vitamin D3 (standard control) (n = 33, 13 males; 20 females). Anthropometrics were measured and blood samples were taken pre- and post-supplementation. Fasting blood glucose, lipids, serum 25(OH)D, and inflammatory markers were measured. COVID-19 symptoms were noted on admission and monitored until full recovery. Results: Vitamin D supplementation for 2 weeks caused a significant increase in serum 25(OH)D levels in the 5000 IU group only (adjusted p = 0.003). Within-group comparisons also showed a significant decrease in BMI and IL-6 levels overtime in both groups (p-values < 0.05) but was not clinically significant in between-group comparisons. Kaplan–Meier survival analysis revealed that the 5000 IU group had a significantly shorter time to recovery (days) than the 1000 IU group in resolving cough, even after adjusting for age, sex, baseline BMI, and D-dimer (6.2 ± 0.8 versus 9.1 ± 0.8; p = 0.039), and ageusia (loss of taste) (11.4 ± 1.0 versus 16.9 ± 1.7; p = 0.035). Conclusion: A 5000 IU daily oral vitamin D3 supplementation for 2 weeks reduces the time to recovery for cough and gustatory sensory loss among patients with sub-optimal vitamin D status and mild to moderate COVID-19 symptoms. The use of 5000 IU vitamin D3 as an adjuvant therapy for COVID-19 patients with suboptimal vitamin D status, even for a short duration, is recommended.

Effect of a Novel Multi-Ingredient Formulation on Management of Dry Eye Discomfort in a Randomized, Double-Blind, Placebo-Controlled Human Clinical Study

Abstract Objectives Dry eye is a chronic condition associated with insufficient tear production and faster tear evaporation and commonly accompanied by inflammation that may lead to ocular surface damage. We have developed a multi-ingredient formulation containing lutein, zeaxanthin, curcumin, and vitamin D3 to address conditions associated with dry eye. The objective of this study was to evaluate the efficacy and safety of our formulation in subjects with mild to moderate dry eye symptoms. Methods This was a randomized, double-blind, parallel, placebo-controlled study. Sixty subjects with mild to moderate DES were randomly assigned in a 1 : 1 ratio to the test or placebo groups. Subjects consumed one capsule of the test or placebo product every morning through the study duration of 56 days. The test product comprised 20 mg lutein, 4 mg zeaxanthin, 200 mg curcuminoids, and 600 IU vitamin D3 in form of a capsule. The placebo product contained soybean oil. Changes in tear volume by Schirmer's test and severity of dry eye discomfort measured by Ocular Surface Disease Index (OSDI) score, changes in Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film break up time (TBUT), corneal &amp; conjunctival staining, tear osmolarity, Matrix Metalloproteinases (MMP)-9 levels in tear fluid, and artificial tear usage were evaluated. Results Thirty subjects in Test and 29 in Placebo group completed study. We observed statistically significant (P &amp;lt; 0.05) improvements in tear volume, TBUT, and a reduction in dry eye discomfort as measured by OSDI and SPEED scores from baseline to day 56 in the Test group. Mean corneal &amp; conjunctival staining scores, tear osmolarity and tear MMP-9 levels also showed significant improvements (P &amp;lt; 0.05) when compared to Placebo on day 56. Artificial tear usage &amp; frequency of usage were significantly reduced (P &amp;lt; 0.05) in test group as compared to Placebo. Products were well tolerated without any adverse events. Conclusions Our multi-ingredient formulation demonstrated significant improvement in dry eye conditions including eye hydration and moisture, tear stability and quality, and overall improvements in eye comfort. Funding Sources OmniActive Health Technologies