Abstract
BackgroundMany observational studies linked vitamin D to cardiometabolic risks besides its pivotal role in musculoskeletal diseases, but evidence from trials is lacking and inconsistent.AimTo determine whether Vitamin D supplementation in urban premenopausal women with vitamin D deficiency can improve cardiometabolic risks and health-related quality of life (HRQOL).DesignA double-blind randomized controlled trial was conducted in Kuala Lumpur, Malaysia. A total of 192 vitamin D deficient (<50 nmol/l) premenopausal women were randomized to receive either vitamin D 50,000 IU or placebo once a week for 2 months and then monthly for 10 months. Primary outcomes were serum 25(OH)D, serum lipid profiles, blood pressure and HOMA-IR measured at baseline, 6 months and 12 months. HRQOL was assessed with SF-36 at baseline and 12 months.ResultsNinety three and ninety-nine women were randomised into intervention and placebo groups respectively. After 12 months, there were significant differences in the serum 25(OH)D concentration (mean difference: 49.54; 95% CI: 43.94 to 55.14) nmol/l) and PTH levels (mean difference: −1.02; 95% CI: −1.67 to −0.38 pmol/l) in the intervention group compared to placebo group. There was significant difference between treatment group in both serum 25(OH)D and PTH. There was no effect of supplementation on HOMA-IR, serum lipid profiles and blood pressure (all p>0.05) between two groups. There was a small but significant improvement in HRQOL in the components of vitality (mean difference: 5.041; 95% CI: 0.709 to 9.374) and mental component score (mean difference: 2.951; 95% CI: 0.573 to 5.329) in the intervention group compared to placebo group.ConclusionLarge and less frequent dosage vitamin D supplementation was safe and effective in the achievement of vitamin D sufficiency. However, there was no improvement in measured cardiometabolic risk factors in premenopausal women. Conversely vitamin D supplementation improves some components of HRQOL.Trial RegistrationAustralian New Zealand Clinical Trial Registry ACTRN12612000452897
Highlights
Vitamin D is well known for its fundamental role in bone mechanism and calcium homeostasis [1,2]
There was no effect of supplementation on homeostasis model assessment insulin resistance (HOMA-insulin resistance (IR)), serum lipid profiles and blood pressure between two groups
There was a small but significant improvement in health-related quality of life (HRQOL) in the components of vitality and mental component score in the intervention group compared to placebo group
Summary
Vitamin D is well known for its fundamental role in bone mechanism and calcium homeostasis [1,2]. Many studies found that vitamin D may play an important role in the prevention of cardiovascular diseases and metabolic syndrome risk factors [2,3,4,5,6]. Clinical trials on the other hand produced inconsistent results [11,12,13,14,15,16,17]. These trials had marked study design variation in terms of samples size, study duration, participants’ characteristics, primary outcomes, intervention dosage and formulation. Many observational studies linked vitamin D to cardiometabolic risks besides its pivotal role in musculoskeletal diseases, but evidence from trials is lacking and inconsistent
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