Health Condition 1: null- females with PCOS
Conditions
Interventions
Intervention1: Vitamin D and Metformin: Drug dosage of Vitamin D is calculated as 4000 units per day and will be given as oral, once a month dose (1,20,000 units on fixed day
baseline, day 30, day 60, day 90, day 120, day 150). As sachet is available in 60,000 units, two sachets will be given on a fixed day every month. Metformin will be initiated at a dose of 500 mg twice
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: Females of age 18-35 years diagnosed as PCOS as per â??Rotterdam criteriaâ?? proposed by The European Society for Human Reproduction and Embryology and the American Society for Reproductive Medicineâ?? in 2003.
Exclusion criteria
Exclusion criteria: 1. Subject who are taking or had taken vitamin D supplementation on last 6 months 2. Subjects who are planning pregnancy in next 6 months or are pregnant. All married females will undergo urine pregnancy test at screening to rule out pregnancy. 3. Past or current history or family history of renal stones 4. Already diagnosed with diabetes (type 1 or 2) as per American Diabetes Association (ADA) criteria 5. Subjects with hypothyroidism. 6. Any systemic disease (cardiac, hepatic, endocrine or renal) or had taken any kind of treatment more than one month in last six months. 7. Diagnosed cases of malabsorption (Celiac disease, Crohnâ??s disease, Ulcerative colitis) or any history suggestive of malabsorption. 8. H/o medications known to interact with vitamin D metabolism (steroids, thiazide diuretics, phenytoin, phenobarbitone, and antitubercular drugs) 9. Known hypersensitivity to vitamin D preparation 10. Subjects who are not willing to come for follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: To study the effect of vitamin D supplementation on Insulin resistance (IR) in subjects with PCOS Primary outcome: HOMA-IR (homeostasis assessment model for insulin resistance) Primary outcome measure: insulin resistance as measured by (Fasting blood glucose x fasting serum insulin)/22.5 Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective: To study the effect of vitamin D supplementation on beta-cell function in patients with PCOS. Secondary outcome as assessed by disposition index Secondary outcome measure will be disposition index calculated as insulinogenic index x Matsuda index Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Manu Goyal
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed