To study the effects of vitamin D supplementation on insulin resistance in Poly-Cystic Ovarian Syndrome (PCOS)

Not Applicable

Conditions: Health Condition 1: null- females with PCOS

Registration Number: CTRI/2014/01/004299

Lead Sponsor: AIIMS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 140

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective: To study the effect of vitamin D supplementation on Insulin resistance (IR) in subjects with PCOS <br/ ><br>Primary outcome: HOMA-IR (homeostasis assessment model for insulin resistance) <br/ ><br>Primary outcome measure: insulin resistance as measured by <br/ ><br> (Fasting blood glucose x fasting serum insulin)/22.5 <br/ ><br> <br/ ><br>Timepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary objective: To study the effect of vitamin D supplementation on beta-cell function in patients with PCOS. <br/ ><br>Secondary outcome as assessed by disposition index <br/ ><br>Secondary outcome measure will be disposition index calculated as insulinogenic index x Matsuda index <br/ ><br>Timepoint: 6 months