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Vitamin D and Valproate monotherapy: RCT

Effect of Daily Vitamin D and Calcium Supplementation on Serum Vitamin D and Calcium Levels in Children with Epilepsy Receiving Sodium Valproate Monotherapy: A Randomized Controlled Trial - ICMR Vitamin D

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035611
Enrollment
100
Registered
2021-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

Intervention1: Vitamin D and calcium: Vitamin D 600IU/day (drops) and 500 mg/day of calcium (tablet) orally WITH sodium valproate drug for 6 months Control Intervention1: Control: only sodium valproat

Sponsors

Indian Council of medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Fulfilling definition of epilepsy as per International League Against Epilepsy, 2017 2. Planned to be started on sodium valproate monotherapy, or started on sodium valproate monotherapy within the last 3 days.

Exclusion criteria

Exclusion criteria: 1. Children with severe vitamin D deficiency (serum 25 hydroxy vitamin D 2. Known chronic renal or liver disease. 3. Severe acute malnutrition. 4. Non-ambulatory and/or tube-fed. 5. Received vitamin D supplementation in the previous 3 months

Design outcomes

Primary

MeasureTime frame
Serum 25-hydroxy vitamin D levels in the two groupsTimepoint: six months—

Secondary

MeasureTime frame
Serum Calcium, Phosphorus, Alkaline phosphatase and Parathyroid hormone (PTH) levelsTimepoint: six months—

Countries

India

Contacts

Public ContactDevendra Mishra

Maulana Azad Medical College

drdmishra@gmail.com911123236031

Outcome results

None listed

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