title: 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.
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.
  
  
  OBJECTIVE
  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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trial Registry ACTRN12612000452897.
authors.affiliation: Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
authors.forename: Mazliza
authors.initials: M
authors.lastname: Ramly
authors.affiliation: Julius Centre University of Malaya, Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
authors.forename: Moy Foong
authors.initials: MF
authors.lastname: Ming
authors.affiliation: Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
authors.forename: Karuthan
authors.initials: K
authors.lastname: Chinna
authors.affiliation: Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
authors.forename: Suhaili
authors.initials: S
authors.lastname: Suboh
authors.affiliation: Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
authors.forename: Rokiah
authors.initials: R
authors.lastname: Pendek
mesh_terms: D000328:Adult; D019587:Dietary Supplements; D005260:Female; D006331:Heart Diseases / Q000453:epidemiology* / Q000209:etiology / Q000378:metabolism; D006801:Humans; D008296:Malaysia / Q000453:epidemiology / Q000208:ethnology; D008875:Middle Aged; D063868:Patient Outcome Assessment; D017697:Premenopause; D011788:Quality of Life; D012306:Risk; D014329:Tropical Climate; D014807:Vitamin D / Q000008:administration & dosage*; D014808:Vitamin D Deficiency / Q000150:complications
chemical_list: D014807:Vitamin D