Comparing Vitamin D Doses in children with Epilepsy on Valproate: 400 IU vs. 600 IU for Bone Health

Comparative efficacy of Daily Oral Vitamin D at 400 IU versus 600 IU for Prevention of Vitamin D Deficiency in Children with Epilepsy Receiving Valproate Monotherapy A Noninferiority Randomised Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/069705

Enrollment

Registered

2024-07-01

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: Oral Vitamin D at 400 IU per day for 3 continous months: Comparative efficacy of Daily Oral Vitamin D at 400 IU v/s 600 IU after 3 months Control Intervention1: Oral Vitamin D at 600 IU

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 2?12 years newly diagnosed (or within 4 days of diagnosis) with epilepsy and prescribed or planned to be prescribed sodium valproate monotherapy.

Exclusion criteria

Exclusion criteria: Abnormal Vitamin D levels at the time of assessment Clinical rickets Presence of chronic renal or liver disease Non ambulatory status or tube fed status Vitamin D supplementaion in last 3 months

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of daily oral vitamin D supplementation at 400 IU and 600 IU in maintaining serum vitamin D levels within the recommended range in children with epilepsy receiving valproate monotherapyTimepoint: 3 months	—

Secondary

Measure	Time frame
To assess the effect of daily oral vitamin D supplementation at 400 IU and 600 IU on serum calcium, phosphate, alkaline phosphatase (ALP), and parathyroid hormone (PTH) levels in children with epilepsy undergoing valproate monotherapy.Timepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Devendra Mishra

Maulana Azad Medical College

drdmishra@gmail.com9968604316

Outcome results

None listed

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