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Effect of vitamin D supplementation on cardiometabolic risks and health-related quality of life among urban premenopausal women in a tropical country--a randomized controlled trial.

AbstractBACKGROUND:
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.
AuthorsMazliza Ramly, Moy Foong Ming, Karuthan Chinna, Suhaili Suboh, Rokiah Pendek
JournalPloS one (PLoS One) Vol. 9 Issue 10 Pg. e110476 ( 2014) ISSN: 1932-6203 [Electronic] United States
PMID25350669 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Vitamin D
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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