The effects of vitamin D2 supplementation on serum high sensitivity C-reactive protein and metabolic profiles in overweight or obese women with PCOS: a randomized, double-blind, placebo-controlled trial
- Conditions
- Overweight or obese women with polycystic ovary syndrome with hypovitaminosis DPCOS, polycystic ovary syndrome, vitamin D2, ergocalciferol, inflammatory markers
- Registration Number
- TCTR20221206004
- Lead Sponsor
- Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University
- Brief Summary
Administration of vitamin D2 40,000 IU per weeks for consecutive 12 weeks in obese or overweight PCOS women with hypovitaminosis D was significant effective to correct their serum 25(OH)D level. However, vitamin D2 supplementation was not found to be significantly more effective than placebo on improvement of and inflammatory marker and metabolic profiles.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 78
1. Diagnosis of PCOS based on the Rotterdam criteria (two of the followings : oligo- and/or anovulation, hyperandrogenism and polycystic ovaries)
2. Overweight or obese women: BMI > 23 kg/m2
3. Serum 25-OH vitamin D < 30 ng/ml
1. Pregnant or breastfeeding women
2. Smoking
3. Diabetes
4. Thyroid dysfunction
5. Hyperprolactinemia
6. Hypertension
7. Cardiovascular or cerebrovascular disease
8. Chronic kidney disease
9. Chronic liver disease
10. Taking any form of vitamin D or calcium supplement within the last 3 months
11. Known hypersensitivity to vitamin D
12. Taking insulin sensitizer eg. Metformin, insulin, antihypertensives, statins of fibrates within the last 3 months
13. Serum calcium > 10.1 mg/dl
14. History of illnesses from infection or trauma that require hospital visit or admission
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method