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

To investigate the effects of Vitamin D supplementation on insulin resistance and beta cell functions in Asian-Indian Subjects with Polycystic Ovarian Syndrome (PCOS): A pilot study

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/07/003792

Enrollment

Registered

2013-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Polycystic Ovarian disease

Interventions

Intervention1: Vitamin D: Dose calculated as 4000 IU per day

given as orally,once a month dose for six months Control Intervention1: Placebo: Placebo

given as orally, once a month for six months

Eligibility

Inclusion criteria

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

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Insulin resistance (IR) and beta cell functionsTimepoint: At baseline and after six months of intervention	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactRajesh Khadgawat

AIIMS

drnishy7@gmail.com9953853334

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026