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Does Vitamin D supplementation affect clinical, metabolic and hormonal profiles of patients with Polycystic Ovary Syndrome (PCOS)

Effect of two different doses of Vitamin D Supplementation on clinical, metabolic and hormonal profiles of Insulin-resistant patients with Polycystic Ovary Syndrome (PCOS):A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/021926
Enrollment
72
Registered
2019-11-08
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 (PCOS)

Interventions

Intervention1: 4000 IU vitamin D per day for 3 months: Patients in Group II will receive metformin 500 mg twice a day along with 4000 IU vitamin D per day for 3 months Control Intervention1: 1000 IU p

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

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 ( 4. BMI 5. Willing to participate in study and follow up

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Difference in HOMA-IR Index before and after the studyTimepoint: 3 months

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Ankita yadav

Department of Obstetrics and Gynecology AIIMS Rishikesh

ankitayadav28101992@gmail.com9810326959

Outcome results

None listed

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