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Effectiveness of Calcium, Vitamin D3 in Vitamin D deficient Polycystic Ovarian Syndrome.

Effectiveness of Calcium, Vitamin D3 in Vitamin D deficient Polycystic Ovarian Syndrome: A Double-Blinded, Placebo-Controlled, Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101822
Enrollment
80
Registered
2026-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Calcium and Vitamin D3: Calcium (500mg/day) and vitamin D3 (250IU/day) with sachet vitamin D3 60,000IU twice a month and standard metformin therapy (500mg/day) for 120 days Control Inte

Sponsors

Tata Motors Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of PCOS as per Rotterdam criteria. Serum25(OH)D less than 20ng per mL Willingness to provide informed consent and comply with study procedures

Exclusion criteria

Exclusion criteria: pregnancy or lactation. Use of Vitamin D, calcium supplements or metformin within the past 3 months. Endocrine disorders: known case of thyroid dysfunction, Cushing s syndrome, hyperprolactinemia. Signiicant comorbidities: known case of renal insufficiency,liver disease, malabsorption syndrome. Contraindications to metformin ( eg: lactic acidosis risk, severe cardiac or respiratory disease)

Design outcomes

Primary

MeasureTime frame
To determine whether combined calcium (500mg/day) with vitamin D3 (250IU/day) daily with vitamin D3 sachet 60,000 IU twice a month along with metformin (500mg/day) compared with 500mg metformin daily with placebo yields a significantly higher proportion of women with regular (21-35 day cyclesTimepoint: To determine whether combined calcium (500mg/day) with vitamin D3 (250IU/day) daily with vitamin D3 sachet 60,000 IU twice a month along with metformin (500mg/day) compared with 500mg metformin daily with placebo yields a significantly higher proportion of women with regular (21-35 day cycles—

Secondary

MeasureTime frame
1. To compare the mean change in BMI between the combined supplement arm & the placebo arm over 16 weeks of treatment. 2. To evaluate the mean change in Ferriman-Gallwey score in participants receiving calcium & vitamin D3 & metformin versus metformin & placebo after 16 weeks of treatment. Timepoint: at baseline & Weeks 4,8,12—

Countries

India

Contacts

Public ContactDR ZARA IBTESAM

Tata Motors Hospital

sgg325135@tatamotors.com9031079040

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026