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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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Cholecalciferol

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No