TCTR20221206004已完成3 期
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
Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University0 个研究点目标入组 78 人开始时间: 2022年12月6日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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
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