Oral Vitamin D3 Research Articles

Nutritional vitamin D is efficacious for reducing intact parathyroid hormone in chronic kidney disease, a prospective interventional study.

To see the efficacy of oral cholecalciferol administered to chronic kidney disease patients with vitamin D deficiency. The prospective interventional study was conducted at the Indus Hospital, Karachi, from January 11, 2017, to January 10, 2018, and comprised diagnosed pre-dialysis chronic kidney disease patients of either gender aged >14 years having vitamin D deficiency. Oral vitamin D 50,000IU was given weekly to those who had severe deficiency <10ng/ml, and every other week to those with less severe 10-25ng/ml deficiency for 3 months. Improvement in vitamin D level was checked along with other chronic kidney disease markers every month over the 3-month period. Data was analysed using SPSS 24. Of the 186 patients enrolled, 129(%) completed the study; 76(58.5%) males and 53(40.8%) females. Overall, 105(81.4%) patients achieved normal vitamin D levels after 3 months of treatment. Significant negative but weak correlation of phosphate, creatinine and intact parathyroid hormone levels was found with vitamin D (p<0.05). Significant positive but weak correlation was found between albumin and vitamin D levels (p<0.05). Significant efficacy of oral vitamin D in chronic kidney disease patients was seen.

800IU versus 400IU per day of vitamin D3 in term breastfed infants: a randomized controlled trial from an LMIC.

This open-label, block-randomized controlled trial compared the effect of 800IU/day and 400IU/day of oral vitamin D3 supplementation in reducing vitamin D insufficiency (VDI) among healthy-term breastfed infants at 14weeks of postnatal age. All eligible infants were randomized to receive either 800 or 400IU/day of oral vitamin D3 (starting within the first week until 14weeks). The primary outcome was the proportion of infants with VDI (25-OH-D < 20ng/ml) at 14weeks. Secondary outcomes were vitamin D deficiency (VDD, < 12ng/ml), severe VDD (< 5ng/ml), anthropometry, biochemical or clinical rickets, and any adverse events related to vitamin D toxicity (VDT). Among 102 enrolled infants, the distribution of baseline variables (including cord 25-OH-D levels; 13.0 versus 14.2ng/ml) was similar in both groups. On intention-to-treat analysis, the proportions of infants with VDI at 14weeks were significantly lower in the 800IU group compared to those in the 400IU group [24% versus 55%; RR 0.44; 95% CI: 0.25-0.76]. The proportions of infants with elevated parathormone (6% versus 26.5%; p = 0.012) and severe VDD (0% versus 12.2%; p = 0.033) were significantly lower in the 800IU group. Clinical rickets developed in three (6.2%) infants in the 400IU group. No infant developed VDT. Conclusions: Daily oral supplementation with 800IU of vitamin D3 resulted in an almost 50% reduction in the proportion of infants with VDI and prevented the occurrence of severe VDD at 14weeks of age compared to 400IU with no evidence of vitamin D toxicity. Trial Registration: Clinical Trial Registry of India (CTRI/2019/02/017374). What is Known: •Breastfeeding is the ideal source of nutrition for healthy-term breastfed infants; however,vitamin D content of breastmilk is suboptimal. •AAP recommends daily oral supplementation of 400 IU of vitamin D to all healthy-term breastfed infants; however, trials from high-income countries support insufficiency of this dose in maintaining serum 25-OH-D levels >20 ng/ml with no such information from low-middle-income countries. What is New: •800 IU/day of oral vitamin D3 supplementation among term breastfed infants significantly reduces vitamin D insufficiency at 14 weeks' age as compared to the recommended dose of 400 IU/day. •This higher supplemental dose is safe with no evidence of vitamin D toxicity.

Cholecalciferol supplementation and angiogenic markers in chronic kidney disease.

Vitamin D plays an important role in proliferation and differentiation of cells and deficiency of vitamin D disturbs angiogenic balance. Previous studies in animal models have reported an association between serum levels of vitamin D and balance between pro- and anti-angiogenic factors. There is insufficient evidence about the effect of vitamin D on mediators of angiogenesis in patients with CKD. We investigated the effect of cholecalciferol supplementation on serum levels of angiogenic markers in non-diabetic patients with CKD stage 3–4. In this secondary analysis on stored samples of our previously published randomized, double-blind, placebo-controlled trial, stable patients of either sex, aged 18–70 years, with non-diabetic CKD stage 3–4 and vitamin D deficiency (serum 25-hydroxyvitamin D ≤20 ng/ml) were randomized to receive either two directly observed oral doses of cholecalciferol (300,000 IU) or matching placebo at baseline and 8 weeks. The primary outcome was change in brachial artery flow-mediated dilatation at 16 weeks. Changes in levels of serum angiogenesis markers (angiopoietin-1, angiopoietin-2, VEGF-A, VEGEF-R, and Tie-2) between groups over 16 weeks were compared. A total 120 patients were enrolled. Supplementation with cholecalciferol led to significant improvement in FMD. Serum 25(OH)D levels were similar in both groups at baseline (13.21±4.78 ng/ml and 13.40±4.42 ng/ml; p = 0.888). At 16 weeks, the serum 25(OH)D levels increased in the cholecalciferol group but not in the placebo group (between-group difference in mean change:23.40 ng/ml; 95% CI, 19.76 to 27.06; p<0.001). Serum levels of angiogenic markers were similar at baseline. At 16 weeks, angiopoietin-2 level decreased in cholecalciferol group (mean difference:-0.73 ng/ml, 95%CI, -1.25 to -0.20, p = 0.002) but not in placebo group (mean difference -0.46 ng/ml, 95%CI, -1.09 to 0.17, p = 0.154), however there was no between-group difference at 16 weeks (between-group difference in mean change: -0.27 ng/ml, 95%CI, -1.09 to 0.55, p = 0.624). Serum angiopoietin-1 level increased [mean change: 5.63 (0.51 to 10.75), p = 0.018] and VEGF-R level decreased [mean change: -87.16 (-131.89 to -42.44), p<0.001] in placebo group but did not show any change in cholecalciferol group. Our data shows the changes in Ang-1, Ang-2 and Ang-1/Ang-2 ratio after high dose oral cholecalciferol supplementation in patients with non-diabetic G3-4 CKD. The data suggests changes in circulating levels of angiogenic markers which needs to be confirmed through an adequately powered study.

Vitamin D supplementation inhibits NF-kß signaling pathway in lean and obese women with PCOS.

This study aims at investigating the effect of vitamin D (VD) replacement therapy on serum nuclear factor-kappa β (NF-kβ) levels in both lean and obese women with Polycystic Ovary Syndrome (PCOS). 50 women with PCOS with VD levels lower than 20 ng/mL were included in the study. Participants were equally divided into two groups, as lean and overweight/obese PCOS, according to their body mass index (BMI) values. Patients in both groups received 2000 IU/day oral VD replacement for two months. Serum NF-kβ, VD, demographic and hormonal values of the patients were recorded before and after VD replacement therapy. Serum insulin and homeostatic model assessment (HOMA-IR) values of overweight/obese women with PCOS were significantly higher than lean women with PCOS. Pre-replacement NF-kβ levels were found to be significantly higher in the overweight/obese PCOS group (3.22 ± 1.09 ng/mL) than in the lean PCOS group (1.22 ± 0.43 ng/mL) (p < 0.03). Serum NF-kβ levels of the patients in the overweight/obese group (1.10 ± 0.30 ng/mL) and the lean group (0.83 ± 0.10 ng/mL) decreased significantly after VD replacement. No significant difference was found between the groups in terms of HOMA-IR, insulin, and total testosterone levels at the end of VD replacement therapy. VD replacement therapy contributes to the improvement of subfertility and metabolic imbalance by reducing serum NF-kβ levels in both lean and obese women with PCOS.

Early Hypocalcemia after Sub-Total, Near-Total and Total Thyroidectomy: its Diagnosis and Treatment Options

Introduction: Hypocalcemia after thyroid surgery is most important and early complication1. The main aim of this study is to diagnose early hypocalcemia after thyroid surgery and its treatment options Method: 100 patients fulfilling inclusion criteria from December 2018 to February 2021 were included in this study who had undergone thyroid surgery (sub-total, near-total and total). Serum calcium less than 8.1 mg/dl, measured after 24 hours to 48 hours of surgery is taken as hypocalcemia. Following variables are assessed in this study, gender, age, pre-operative serum calcium levels and type of surgery. Hypocalcemia diagnosed by post-operative serum calcium levels, presence of numbness, Chvostek’s sign or Trousseau’s sign noted and analyzed by SPSS v20 was used for statistical analysis. p-value less than 0.05 was considered as statistically significant. Results: Early post-hypocalcemia developed in 71 (71%) patients of them 13(18%) were males and 58 (82%) were females and female gender is significantly more associated with hypocalcemia (p=0.001) Type of surgery (sub-total, near-total and total) is not related to development of early hypocalcemia (p=0.169). Patients who developed early hypocalcemia divided into two groups- A and B respectively. Group A is treated with oral calcium alone and B with oral calcium combined with Vitamin D3. The patients followed up for 6 months. The patients who treated with oral calcium and vitamin D3 combined responded well as compares with oral calcium alone (p=.001). Conclusion: This study suggests that female gender is associated with early hypocalcemia however there is no significant different type of surgery and patients who treated with oral calcium combined with vitamin D3 responded well as compared with oral calcium alone. Keywords: Early Hypocalcemia, thyroid surgery, Goiter

Outcome of Cholecalciferol Supplementation on Bone Mineral metabolism in End Stage Renal Disease Patients in Comparison with Placebo- Randomized Control Trial

Objectives: This study was conducted to evaluate the impact of oral cholecalciferol intake on Bone Mineral Metabolism [i.e. levels of 25-hydroxyvitamin-D, alkaline phosphatase (ALP), intact parathyroid hormone (iPTH), calcium (Ca), phosphorus (P), calcium-phosphorus product (CaxP)] and to ascertain its effects on markers of inflammation [i.e. C-reactive protein (CRP), white blood cell count (WBC)] and chronic musculoskeletal symptoms (musculoskeletal pain or fatigue) Study Design: Double blind randomized controlled trial. Place and Duration of Study: Shaikh Zayed Hospital, Lahore, over a period of 2 months from November 2015 to Jan 2016. Methods: 70 patients on maintenance hemodialysis in Shaikh Zayed Hospital Lahore, fulfilling inclusion criteria received weekly doses of cholecalciferol or placebo according to 25-hydroxyvitamin-D levels. All patients were evaluated at 0 month and 2 months after supplementation. Level of 25-hydroxyvitamin-D, hemoglobin, white blood cell count, intact PTH, alkaline phosphatase, calcium, phosphorus, calcium phosphorus product, C reactive protein, albumin and scale of chronic pain/fatigue with visual analog scale was compared at day 0 and after 2 months of treatment. Results: There was substantial increment in 25 OH vitamin D levels after cholecalciferol intake whereas there was reduction in vitamin D levels in patients receiving placebo. In the cholcalciferol group only 14% achieved therapeutic levels of &gt;30 pg/dl while 60% had levels &gt;25 pg/dl. There was minor change in iPTH, calcium, phosphorus, calcium phosphorus product and alkaline phosphate levels in cholcalciferol group as compared to placebo (p value = 0.484, 0.067, 0.359, 0.061, 0.12 respectively). There was significant improvement of chronic musculoskeletal pain (p value=0.00) and CRP (p value=0.005) with cholecalciferol supplementation compared to placebo. Hemoglobin, white blood cell count, albumin level had no significant difference in both the groups. Conclusion: Cholecalciferol supplementation was effective in reduction of chronic musculoskeletal symptoms and marker of inflammation like CRP but does not show difference in term of iPTH, calcium, phosphorus calcium phosphorus product, alkaline phosphate, hemoglobin, albumin level and WBC count. Keywords: ESRD, Vitamin D3, 25 hydoxyvitamin D, Metabolic Bone disease

Oral Cholecalciferol Supplementation in Sahara Black People with Chronic Kidney Disease Modulates Cytokine Storm, Oxidative Stress Damage and Athero-Thromboembolic Risk.

The 25-hydroxyvitamin D3 (25OHD3) deficiency in chronic kidney disease (CKD) is associated with immune system dysfunction (pro-inflammatory cytokines storm) through macrophages renal infiltration, oxidative stress (OxS) damage and athero-thromboembolic risk. Conversely, cholecalciferol supplementation (25OHD-S) prevents kidney fibrosis by inhibition of vascular calcification and nephrotic apoptosis (nephrons reduction). The objective of this study was to investigate the pleiotropic effects of 25OHD-S on immunomodulation, antioxidant status and in protecting against thromboembolic events in deficiency CKD Black and White individuals living in the Southern Sahara (SS). The oral 25OHD-S was evaluated in 60,000 IU/month/36 weeks versus in 2000 IU/day/24 weeks in Black (n = 156) and White (n = 150). Total serum vitamin D was determined by liquid chromatography-tandem mass spectrometry. All biomarkers of pro-inflammatory cytokines (PIC) were assessed by ELISA tests. OxS markers were assessed by Randox kits. Homocysteine and lipoproteine (a) were evaluated by biochemical methods as biomarkers of atherothromboembolic risk. All statistical analyses were performed with Student’s t-test and one-way ANOVA. The Pearson test was used to calculate the correlation coefficient. The means will be significantly different at a level of p value < 0.05. Multiple logistic regressions were performed using Epi-info and Statview software. Vitamin D deficiency alters the PIC profile, OxS damage and atherothrombogenic biomarkers in both SS groups in the same manner; however, these disorders are more acute in Black compared to White SS individuals. The results showed that the serum 25OHD3 concentrations became normal (>75 nmol/L or >30 ng/mL) in the two groups. We have shown that the dose and duration of 25OHD-S treatment are not similar in Black SS residents compared to White SS subjects, whilst the same inhabit the south Sahara environment. It appears that a high dose intermittent over a long period (D60: 36 weeks) was more efficient in Black people; while a lower dose for a short time is sufficient (D2: 24 weeks) in their White counterparts. The oral 25OHD-S attenuates PIC overproduction and OxS damage, but does not reduce athero-thromboembolic risk, particularly in Black SS residents.

Effect of vitamin D treatment on magnesium levels in chronic hemodialysis patient; a double blind controlled clinical trial

Introduction: The homeostasis of magnesium (Mg) is impaired in chronic kidney disease (CKD) and it has been suggested that intestinal absorption of Mg may be affected by vitamin D status. 25-Hydroxy vitamin D or 25(OH)D deficiency is common in patients undergoing chronic hemodialysis; however the efficacy of nutritional vitamin D supplementation on Mg level in this population remains uncertain. Objectives: The aim of this study was to evaluate the effect of vitamin D treatment on Mg levels in chronic hemodialysis patients. Patients and Methods: This randomized clinical trial study was conducted on 69 chronic hemodialysis patients (mean age of 56.93 ±12.26 years) with serum 25-hydroxy vitamin D levels &lt;30 ng/mL. The patients were randomly assigned to one of treatment groups of oral vitamin D3- 50 000 units per week (n=35; experimental group) or 500 mg calcium D3 tablets, every 12 hours (n=34; control group) for three months. At the beginning and end of the treatment period, the levels of serum 25-hydroxy vitamin D and the levels of Mg, calcium, phosphorus and intact parathyroid hormone (iPTH) were measured in two groups. Results: In both groups, serum vitamin D levels increased significantly after treatment (P&lt;0.0001 for both groups), however after three months of treatment, in the experimental group the levels of vitamin D were significantly higher than the patients in the control group (57 ng/mL versus 28 ng/mL; P&lt;0.0001) and the median increase of vitamin D after treatment in the experimental group was significantly higher than the control group (40 ng/mL versus 10.5; P&lt;0.0001). Serum Mg levels before and after treatment were not significantly different between two groups (P=0.880 and P=0.434). In this study, we found no significant correlation between serum vitamin D level with serum Mg, calcium, phosphate, and parathyroid Hormone levels (P&gt;0.05). Conclusion: Our study shows that oral vitamin D therapy can increase 25(OH)D levels in maintenance hemodialysis patients without significant alterations in serum calcium, phosphate, magnesium and parathyroid hormone during a 12-week period. Trial Registration: Registration of trial protocol has been approved by the Iranian registry of clinical trial (#IRCT20210314050698N1; https://en.irct.ir/trial/55159, local ethical code# IR.SKUMS.REC.1397.181).

High-dose vitamin D versus placebo to prevent complications in COVID-19 patients: Multicentre randomized controlled clinical trial.

The role of oral vitamin D3 supplementation for hospitalized patients with COVID-19 remains to be determined. The study was aimed to evaluate whether vitamin D3 supplementation could prevent respiratory worsening among hospitalized patients with COVID-19. We designed a multicentre, randomized, double-blind, sequential, placebo-controlled clinical trial. The study was conducted in 17 second and third level hospitals, located in four provinces of Argentina, from 14 August 2020 to 22 June 2021. We enrolled 218 adult patients, hospitalized in general wards with SARS-CoV-2 confirmed infection, mild-to-moderate COVID-19 and risk factors for disease progression. Participants were randomized to a single oral dose of 500 000 IU of vitamin D3 or matching placebo. Randomization ratio was 1:1, with permuted blocks and stratified for study site, diabetes and age (≤60 vs >60 years). The primary outcome was the change in the respiratory Sepsis related Organ Failure Assessment score between baseline and the highest value recorded up to day 7. Secondary outcomes included the length of hospital stay; intensive care unit admission; and in-hospital mortality. Overall, 115 participants were assigned to vitamin D3 and 105 to placebo (mean [SD] age, 59.1 [10.7] years; 103 [47.2%] women). There were no significant differences in the primary outcome between groups (median [IQR] 0.0 [0.0-1.0] vs 0.0 [0.0-1.0], for vitamin D3 and placebo, respectively; p = 0.925). Median [IQR] length of hospital stay was not significantly different between vitamin D3 group (6.0 [4.0-9.0] days) and placebo group (6.0 [4.0-10.0] days; p = 0.632). There were no significant differences for intensive care unit admissions (7.8% vs 10.7%; RR 0.73; 95% CI 0.32 to 1.70; p = 0.622), or in-hospital mortality (4.3% vs 1.9%; RR 2.24; 95% CI 0.44 to 11.29; p = 0.451). There were no significant differences in serious adverse events (vitamin D3 = 14.8%, placebo = 11.7%). Among hospitalized patients with mild-to-moderate COVID-19 and risk factors, a single high oral dose of vitamin D3 as compared with placebo, did not prevent the respiratory worsening. ClincicalTrials.gov Identifier: NCT04411446.

Effect of Oral Vitamin D3 on Dental Caries: An In-Vivo and In-Vitro Study.

AimVitamin D3 plays an important role in affecting the overall remineralization process of the dentition. The use of supplements help to keep the levels at optimum and thus reduce the chances of treating very early lesion of caries. Hence the aim was to investigate the indirect effects of oral vitamin D3 on microhardness and elemental weight percentage of Calcium (Ca) and Phosphorous (P) in enamel surface with an artificially initiated carious lesion.MethodsThe 120 extracted premolars were randomly divided into five groups according to salivary immersion. Each group had a total of twenty-four participants, with the following characteristics: control +ve: sound enamel; control -ve: only subjected to pH cycle; A: pH cycle and immersion in control saliva; B: pH cycle and saliva collected after three weeks; and C: pH cycle and saliva collected after six weeks. The unstimulated saliva was collected from (40) adult volunteers receiving vitamin D3 1000IU gel capsules daily for six weeks. Before each vitamin D3 intake, 10 mL of unstimulated control saliva was collected from each participant. Then other 10 ml. were collected after three and six weeks of vitamin D receiving periods. Saliva immersion time (12 hours). Enamel surface was assessed by Vicker’s Microhardness machine and (X-ray fluorescence - XRF) spectrometer.ResultsFor all specimens, there was a significant decrease in both (Ca and P weight %) after demineralization and then they significantly increased after receiving vitamin D3. The microhardness and elemental analysis provide confirmed results that were represented as a statistically significant difference at (P≤ 0.05) between groups that received vitamin D3 and those without vitamin D3 dosage.ConclusionsOral vitamin D3 has a significant potential in motivating remineralization of early lesions on the enamel surfaces representing improved surface microhardness and minerals content (Ca and P weight %) of demineralized tooth surfaces.

Vitamin D Profile and Disease Activity of JIA During Pandemic Covid-19

Vitamin D (25-Hydroxyvitamin D3 [25(OH)D3]) has an important role in the immune system. This study aimed to assess the relationship between 25-Hydroxyvitamin D3 and disease activity in Indonesian children with Juvenile Idiopathic Arthritis (JIA) during pandemic Covid-19. A 12-week randomized control trial was undertaken at Saiful Anwar Hospital between June and September 2021. JIA patients are divided into two groups. The control group (CG), without supplementation, and the treatment group (TG) got a high dose of oral cholecalciferol 2000 IU/day. Serum levels of 25(OH)D3 were measured using an enzyme-linked immunosorbent assay (ELISA). Comparison between serum 25(OH)D3 levels and JIA subtypes, peripheral blood Creactive protein (CRP), erythrocyte sedimentation rate (ESR), and Juvenile Arthritis Disease Activity Score (JADAS-27 Score) were analyzed using SPSS. There was a significant increase in serum 25(OH)D3 levels in treatment group (mean: 27.38 ± 6.39 ng/ml vs 42.26 ± 10.95 ng/ml; P=0.000). The JADAS-27 score significantly decrease in treatment group (14.60 ± 4.04 vs 6.24 ± 1.96; p= 0.000). Serum 25(OH)D3 showed a significant correlation with the JADAS-27 score. The levels of 25(OH)D3 are significantly decreased in children with JIA. Decreased 25(OH)D3 levels may be associated with the etiopathogenesis of JIA. Vitamin D levels have correlations with disease activity. Adjunctive treatment of cholecalciferol improves the disease activity in JIA patients. Keywords: Disease activity, JIA, Pandemic Covid-19, Vitamin D

Daily v. weekly oral vitamin D3 therapy for nutritional rickets in Indian children: a randomised controlled open-label trial.

The aim of the study was to compare the efficacy of daily v. weekly oral vitamin D3 therapy in radiological healing of nutritional rickets. Children 6 months to 12 years (n 132) diagnosed with nutritional rickets were randomised into three groups (n 44): group A - 2000 IU daily vitamin D3 for 12 weeks, B - 60000 IU weekly for 3 weeks, C - 60000 IU weekly for 6 weeks. Serum calcium, phosphorus, 25-hydroxyvitamin D (25(OH)D), parathyroid hormone and X-ray score were estimated at baseline and 12 weeks (endline). The proportion of children who achieved complete radiological healing at endline was compared between three groups by χ2 and delta change in laboratory parameters by ANOVA (parametric data) or Kruskal Wallis test (non-parametric data), respectively. Baseline 25(OH)D ≤ 20 ng/ml was seen in 119 (90·2 %), hyperparathyroidism in 90 (68·8 %) and hypocalcaemia in 96 (72·7 %). A total of 120/132 children completed the study. Complete radiological healing seen in 30 (75 %) in group A, 23 (60·5 %) in group B and 26 (61·9 %) in group C; P = 0·15, with comparable endline X-ray scores; P = 0·31. The median (interquartile range (IQR)) delta X-ray score (baseline-endline) was 7 (4,9), 5 (2·25, 6) and 6 (4,7) in groups A, B and C, respectively; P = 0·019. Median (IQR) 25(OH)D endline levels in groups A, B and C were 50·0 (26·5, 66·5), 42·1 (28·4, 54·4) and 53·5 (33·7, 71·2) ng/ml, respectively; P = 0·045. Radiological scores were comparable at endline among daily and weekly vitamin D groups with greater change from baseline in daily supplemented group.

Oral vitamin D3 supplementation for femtosecond LASIK-associated dry eye vitamin D for LASIK dry eye syndrome.

To assess the effect of oral vitamin D3 supplementation in dry eye after femtosecond laser-assisted in situ keratomileusis (FS-LASIK). Liuzhou Worker's Hospital. This prospective study included 90 patients selected between January and December in 2019, who underwent FS-LASIK operation in our hospital and had obvious symptoms indicating dry eyes 1month after operation. The subjects were randomly divided into two groups: The experimental group (n = 45) received vitamin D3 2000IU/D continuously for 12weeks; the control group (n = 45) did not take vitamin D3 orally. Ocular surface disease index (OSDI), Tear breakup time (TBUT) and Schirmer's test I were evaluated premedication and 1,3,6months after treatment. Serum vitamin D3 level and the mean concentration of cytokine IL-6, IL-17, IL-23 in t ears were also measured. One month after treatment, the mean OSDI score of the experimental group (11.67 ± 8.53) was significantly lower than that of the control group (23.82 ± 13.22) (P = 0.007). TBUT (10.71 ± 1.02s) and Schirmer I (9.36 ± 0.40mm) of the experimental group were higher than those of the control group (7.49 ± 1.29s and 7.51 ± 0.44mm). The OSDI (10.25 ± 5.49) was significantly lower than those of the control group(20.22 ± 6.23) and TBUT (10.75 ± 1.09s) and Schirmer I test value (11.34 ± 0.39mm) of the experimental group were significantly higher than those of the control group (8.36 ± 1.23, 8.12 ± 0.50) at 3months after treatment. There were significant differences in OSDI, TBUT (P < 0.05) and Schirmer I test value between the two groups at 6months after treatment. Serum vitamin D3 level was negatively correlated with OSDI score (r = - 0.90; P = 0.00) and positively correlated with Schirmer I test (r = 0.88; P = 0.00), TBUT score (r = 0.89; P = 0.00) and TMH (r = 0.80; P = 0.00). IL-17 level was shown to be significantly correlated with TBUT(r = - 0.25, P = 0.014) and Schirmer I test (r = - 0.21, P = 0.018). IL-6 level was significantly correlated with OSDI (R = 0.18, P = 0.020) and TBUT (R = 0.20, P = 0.019).

Hypovitaminosis D and Hashimoto's thyroiditis: effects of four-month supplementation therapy with oral cholecalciferol

Hypovitaminosis D and Hashimoto's thyroiditis: effects of four-month supplementation therapy with oral cholecalciferol

A randomized, double-blind, placebo-controlled trial of vitamin D supplementation with or without calcium in community-dwelling vitamin D deficient subjects

BackgroundAlthough vitamin D deficiency is highly prevalent in the Middle East, very few studies have attempted to measure its health impact.AimsWe aimed to assess whether vitamin D3 and calcium, either alone or in combination, have health benefit.MethodsIn a 2 × 2 factorial design double-blind, placebo-controlled trial, Community free living adults living in the city of Al Ain, UAE were randomly assigned to receive daily 2000 IU oral vitamin D3 alone, 600 mg calcium alone, oral vitamin D3 (2000 IU per day) combined with 600 mg calcium, or a placebo for 6 months. Primary outcomes were self-rated health and bone turnover markers.ResultsOf the 545 randomized, 277 subjects completed 6 months follow up. 25(OH)D levels marginally increased in the two groups received vitamin D3 alone or combined with calcium compared to the decline seen in those who received calcium supplement alone or a placebo. Sub-group analysis revealed that parathyroid hormone (PTH) concentration decreased and Calcium/creatinine ratio increased significantly in the combined vitamin D and Calcium group compared to the vitamin D alone or Calcium alone in contrast to the increase seen in the placebo group [p < 0.05 for between group difference at 6 months]. There were no statistically significant differences between the supplement and placebo groups at the 6 months follow-up in body weight, body mass index (BMI), blood pressure, body pains and general health.ConclusionPTH concentration decreased and calcium/creatinine ratio increased in subjects who received vitamin D and Calcium together compared to those who received vitamin D alone.Trial registrationNCT02662491, First registered on 25 January 2016 (https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00060CE&selectaction=Edit&uid=U0001M6P&ts=3&cx=scu4cb, Last update: 05 August 2019.

Effect of Vitamin D Supplementation in Type 2 Diabetes Patients with Tuberculosis: A Systematic Review

Diabetes mellitus (DM) and tuberculosis (TB) have been recognized as reemerging epidemics, especially in developing countries. Among all the risk factors, diabetes causes immunosuppression, increasing the risk of active TB three times. Vitamin D has been found as a link between DM-TB co-morbidity. Vitamin D affects the immune response, suppresses Mycobacterium tuberculosis (Mtb) growth, and affects insulin secretion. The present systematic review determines the effect of vitamin D supplementation on clinical and therapeutic outcomes of DM-TB patients. A comprehensive literature search was carried out in PubMed, Cochrane, Web of Science, and Scopus database to determine eligible studies from inception to January 2021. Out of the 639 articles retrieved, three randomized controlled trials (RCTs) were included in the systematic review. The effect of vitamin D3 or oral cholecalciferol supplementation was assessed on outcomes, such as duration to sputum smear conversion, TB scores improvement, change in glycemic parameters, including HbA1c, FBS, and PLBS, and laboratory parameters, such as Hb, ESR, and CRP. Duration of sputum smear conversion was decreased by two weeks in the vitamin D3 supplemented group in two studies. TB score improvement and changes in glycemic parameters were inclined towards supplemented group; however, they were not significant. The overall effect of vitamin D3 supplementation on TB patients with DM was not significant. Further studies are required in the future examining the effect of supplementation on outcomes in this population.

Analysis of the Seasonal Fluctuation of γδ T Cells and Its Potential Relation with Vitamin D3.

In addition to its role in bone metabolism, vitamin D3 exerts immunomodulatory effects and has been proposed to contribute to seasonal variation of immune cells. This might be linked to higher vitamin D3 levels in summer than in winter due to differential sun exposure. γδ T cells comprise a numerically small subset of T cells in the blood, which contribute to anti-infective and antitumor immunity. We studied the seasonal fluctuation of γδ T cells, the possible influence of vitamin D3, and the effect of the active metabolite 1α,25(OH)2D3 on the in vitro activation of human γδ T cells. In a retrospective analysis with 2625 samples of random blood donors, we observed higher proportions of γδ T cells in winter when compared with summer. In a prospective study over one year with a small cohort of healthy adults who did or did not take oral vitamin D3 supplementation, higher proportions of γδ T cells were present in donors without oral vitamin D3 uptake, particularly in spring. However, γδ T cell frequency in blood did not directly correlate with serum levels of 25(OH)D3. The active metabolite 1α,25(OH)2D3 inhibited the in vitro activation of γδ T cells at the level of proliferation, cytotoxicity, and interferon-γ production. Our study reveals novel insights into the seasonal fluctuation of γδ T cells and the immunomodulatory effects of vitamin D3.

The effects of vitamin D supplementation on postoperative atrial fibrillation after coronary artery bypass grafting in patients with vitamin D deficiency.

Postoperative atrial fibrillation (POAF) as a common complication of coronary artery bypass grafting (CABG) surgery is associated with increased mortality and morbidity rates. Vitamin D deficiency increases the prevalence of POAF; however, the effects of vitamin D supplementation on the incidence of POAF have not yet been completely elucidated. In this prospective, open-label, randomized clinical trial the level of 25-hydroxy vitamin D (25(OH) D) was measured in patients undergoing CABG surgery. Patients with vitamin D insufficiency (defined as 25(OH) D level < 30 ng/ml) were included and randomly assigned to control group to receive either the general standard of care (Group A) or to study group to receive the general standard of care plus oral vitamin D3 , 600,000 IU 5 days before surgery(Group B). The primary outcome of our study was the occurrence of POAF during the first 5 days after CABG surgery. Totally, 93 patients in group B and 103 patients in group A completed the study. The occurrence of POAF was significantly lower in group B as compared to group A (9.68% vs. 20.39%, p = .038). The length of intensive care unit(ICU) stay and hospital stay were reduced in group B patients (2.21 vs. 3.86 days, p < .001 and 7.40 vs. 9.58 days, p = .022, respectively). Our study demonstrated that vitamin D supplementation reduces the incidence of POAF, duration of ICU, and hospital stay following CABG surgery.

Safety Data in Patients with Autoimmune Diseases during Treatment with High Doses of Vitamin D3 According to the "Coimbra Protocol".

Background: In 2013, the group of Cicero Coimbra, Brazil, reported the clinical efficacy of high doses of vitamin D3 in patients suffering from autoimmune skin disorders (“Coimbra protocol”, CP). However, hypercalcemia and the subsequent impaired renal function may be major concerns raised against this protocol. Methods: We report for the first time for a broad spectrum of autoimmune diseases in 319 patients (mean age (±SD) 43.3 ± 14.6 years, 65.5% female, 34.5% male) safety data for high doses of orally applied vitamin D3 (treatment period: up to 3.5 years) accompanied by a strict low-calcium diet and regular daily fluid intake of at least 2.5 L. Results: Mean vitamin D3 dose was 35,291 ± 21,791 IU per day. The measurement of more than 6100 single relevant laboratory parameters showed all mean values (±SD) within the normal range for total serum calcium (2.4 ± 0.1 mmol/L), serum creatinine (0.8 ± 0.2 mg/dL), serum creatinine associated estimated GFR (92.5 ± 17.3 mL/min), serum cystatin C (0.88 ± 0.19 mg/L), serum TSH (1.8 ± 1 mIU/L), and for 24 h urinary calcium secretion (6.9 ± 3.3 mmol/24 h). We found a very weak relationship between the dosage of oral vitamin D3 and the subsequent calcium levels, both in serum and in urinary excretion over 24 h, respectively. Conclusions: Our data show the reliable safety of the CP in autoimmune patients under appropriate supervision by experienced physicians.

Bioavailability by design — Vitamin D3 liposomal delivery vehicles

Vitamin D3 deficiency has serious health consequences, as demonstrated by its effect on severity and recovery after COVID-19 infection. Because of high hydrophobicity, its absorption and subsequent redistribution throughout the body are inherently dependent on the accompanying lipids and/or proteins. The effective oral vitamin D3 formulation should ensure penetration of the mucus layer followed by internalization by competent cells. Isothermal titration calorimetry and computer simulations show that vitamin D3 molecules cannot leave the hydrophobic environment, indicating that their absorption is predominantly driven by the digestion of the delivery vehicle. In the clinical experiment, liposomal vitamin D3 was compared to the oily formulation. The results obtained show that liposomal vitamin D3 causes a rapid increase in the plasma concentration of calcidiol. No such effect was observed when the oily formulation was used. The effect was especially pronounced for people with severe vitamin D3 deficiency.