Does Vitamin D supplementation affect clinical, metabolic and hormonal profiles of patients with Polycystic Ovary Syndrome (PCOS)
Phase 4
- Conditions
- Health Condition 1: null- Polycystic ovarian disease (PCOS)
- Registration Number
- CTRI/2019/11/021926
- Lead Sponsor
- AIIMS Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Women in the age group 15-45 years.
2. Patient of Polycystic Ovarian Syndrome(PCOS) with Insulin resistance.
3. Women with low Vit D level ( <20ng/ml)
4. BMI < 30 kg/m2
5. Willing to participate in study and follow up
Exclusion Criteria
1.Patient already on other drugs for treatment of PCOS like Oral Contraceptive Pills
2.Deranged kidney or liver function tests
3.Uncontrolled Thyroid disorders or Hyperprolactinemia
4.Type II DM
5.Medication that interfere with vitamin D levels
6.Women with any other endocrinological disorders like congenital adrenal hyperplasia, Cushingâ??s syndrome or androgen-secreting tumors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in HOMA-IR Index before and after the studyTimepoint: 3 months
- Secondary Outcome Measures
Name Time Method To compare the improvement in the metabolic and hormonal parameters after treatment in both the groupsTimepoint: 3 months;To study the improvement in clinical parameters like menstrual cycle, BMI, waist to hip circumference, hirsutism, and acne in women with PCOS after treatment in both groupsTimepoint: 3 months;To study the varied clinical presentation of PCOSTimepoint: 3 months