Effects of Vitamin D supplementation in Subjects with Polycystic Ovarian Syndrome (PCOS)

Phase 2

Conditions: Health Condition 1: null- Polycystic Ovarian disease

Registration Number: CTRI/2013/07/003792

Lead Sponsor: All India Institute of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Asian Indian Females 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 were taking or had taken vitamin D supplementation on last 6 months

2.Subjects who were planning pregnancy in next 6 months or were pregnant. All married females underwent urine pregnancy test at screening to rule out pregnancy.

3.Past or current history or family history of renal stones

4.Subjects already diagnosed with diabetes (type 1 or 2) as per American Diabetes Association (ADA) criteria

5. Any systemic disease (cardiac, hepatic, endocrine or renal) or had taken any kind of treatment more than one month in last six months.

6.Diagnosed cases of malabsorption (Celiac disease, Crohnâ??s disease, Ulcerative colitis) or any history suggestive of malabsorption.

7.H/o medications known to interact with vitamin D metabolism (steroids, thiazide diuretics, phenytoin, phenobarbitone, and antitubercular drugs)

8.Known hypersensitivity to vitamin D preparation

9.Subjects who were not willing to come for follow-up

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin resistance (IR) and beta cell functionsTimepoint: At baseline and after six months of intervention

Secondary Outcome Measures

Name	Time	Method
Cardiovascular risk factors - aortic pulse wave velocity (AoPWV) and Augmentation index (AI) by radial pulse wave analysis in subjects with PCOS.Timepoint: At baseline and after six months of intervention