Effect of Three Different Doses of Oral Cholecalciferol on 25-Hydroxyvitamin D Changes Among Epilepsy Patients With Hypovitaminosis D

Phase 4

Completed

• Conditions: Epilepsy
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT02890823
• Lead Sponsor: Chulalongkorn University

Brief Summary

To characterize the effect of three different doses of vitamin D3 supplementation on serum 25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs), and to determine the prevalence of and risk factors for hypovitaminosis D among Thai patients with epilepsy.

Detailed Description

A single-blinded prospective, randomized study undertaken at epilepsy clinic of King Chulalongkorn Memorial Hospital. The patients with hypovitaminosis D were included and divided into two groups according to the type of AEDs use. Patients receiving each AEDs type were randomly assigned to receive vitamin D3 1000, 3000 or 6000 IU once daily. The mean increment in serum 25(OH)D levels were measured at 8 and 16 weeks.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-09
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-06
• Last Update Submitted: 2016-09-06
• Study First Posted: 2016-09-07
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Epilepsy patients, age ≥ 15 years, BMI18 - 30 kg/m2
• Being treated with either enzyme inducing antiepileptic drugs (EIAEDs: phenytoin, phenobarbital, carbamazepine and topiramate) or non-enzyme inducing antiepileptic drugs (Non-EIAEDs: sodium valproate, levetiracetam, and lamotrigine) at a stable dosage regimen for at least a year.
• Serum 25(OH)D <30ng/ml

Exclusion Criteria

• Patients with a history of hypercalcemia, nephrolithiasis, fractures, hepatic disease, kidney disease, granulomatous disease or currently supplemented with vitamin D.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EIAEDs-1000	Cholecalciferol	Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily
EIAEDs-3000	Cholecalciferol	Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily
non-EIAEDs-6000	Cholecalciferol	Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily
EIAEDs-6000	Cholecalciferol	Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily
non-EIAEDs-1000	Cholecalciferol	Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily
non-EIAEDs-3000	Cholecalciferol	Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily

Primary Outcome Measures

Name	Time	Method
serum 25-hydroxyvitamin D changes in patients who received enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs) at the same dosage of cholecalciferal	8 and 16 months

Secondary Outcome Measures

Name	Time	Method
Number (percentage) of the patients who have serum 25-hydroxyvitamin D levels more than 30ng/ml	16 months