EFFECT OF DAILY VITAMIN D SUPPLEMENTATION ON VITAMIN D LEVELS AT 3 MONTHS IN CHILDREN WITH EPILEPSY RECEIVING SODIUM VALPROATE MONOTHERAPY

Phase 3

Completed

• Conditions: Hypovitaminosis D in children with epilepsy

• Registration Number: TCTR20200621002
• Lead Sponsor: Maulana Azad Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-01-15
• Study Start: 2020-06-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Fulfilling definition of epilepsy, as per International League Against Epilepsy (ILAE, 2014): -
•At least two unprovoked (or reflex) seizures occurring more than 24 hours apart.
•One unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next 10 years.
•Diagnosis of an Epilepsy syndrome.
2.Planned to be started on sodium valproate monotherapy.
3.Baseline serum 25-hydroxy vitamin D level >20 ng/mL.

Exclusion Criteria

1.Known chronic renal or liver disease.
2.Non-ambulatory and/or tube-fed.
3.Received vitamin D supplementation in the last 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum 25-hydroxy vitamin D level 3 months of intervention Electrochemoluminescence binding assay (ECLIA)

Secondary Outcome Measures

Name	Time	Method
Serum Parathyroid hormone 3 months of intervention Electrochemiluminescence binding assay (ECLIA),Serum calcium 3 months of intervention SPECTROPHOTOMETRY,Ionized calcium 3 months of intervention Ion Selective Electrode (ISE),Serum Phosphate 3 months of intervention Photometric Assay,Alkaline Phosphate 3 months of intervention Calorimetric assay