Abstract | BACKGROUND: Many observational studies linked vitamin D to cardiometabolic risks besides its pivotal role in musculoskeletal diseases, but evidence from trials is lacking and inconsistent. AIM: To determine whether Vitamin D supplementation in urban premenopausal women with vitamin D deficiency can improve cardiometabolic risks and health-related quality of life (HRQOL). DESIGN: A 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. RESULTS: Ninety 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. CONCLUSION: Large 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 REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12612000452897.
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Authors | Mazliza Ramly, Moy Foong Ming, Karuthan Chinna, Suhaili Suboh, Rokiah Pendek |
Journal | PloS one
(PLoS One)
Vol. 9
Issue 10
Pg. e110476
( 2014)
ISSN: 1932-6203 [Electronic] United States |
PMID | 25350669
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Adult
- Dietary Supplements
- Female
- Heart Diseases
(epidemiology, etiology, metabolism)
- Humans
- Malaysia
(epidemiology, ethnology)
- Middle Aged
- Patient Outcome Assessment
- Premenopause
- Quality of Life
- Risk
- Tropical Climate
- Vitamin D
(administration & dosage)
- Vitamin D Deficiency
(complications)
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