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

Study Overview
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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.

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.

Official Title
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EFFECT OF THREE DIFFERENT DOSES OF ORAL CHOLECALCIFEROL (1000 IU, 3000 IU AND 6000 IU DAILY) ON SERUM 25-HYDROXYVITAMIN D CHANGES AMONG EPILEPSY PATIENTS WITH HYPOVITAMINOSIS D: A RANDOMIZED PROSPECTIVE STUDY

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EIAEDs-1000<br>Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily | Drug: Cholecalciferol<br> <br> |
| Experimental: EIAEDs-3000<br>Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily | Drug: Cholecalciferol<br> <br> |
| Experimental: EIAEDs-6000<br>Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily | Drug: Cholecalciferol<br> <br> |
| Active Comparator: non-EIAEDs-1000<br>Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily | Drug: Cholecalciferol<br> <br> |
| Active Comparator: non-EIAEDs-3000<br>Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily | Drug: Cholecalciferol<br> <br> |
| Active Comparator: non-EIAEDs-6000<br>Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily | Drug: Cholecalciferol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (percentage) of the patients who have serum 25-hydroxyvitamin D levels more than 30ng/ml |  | 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiepileptic Drugs, Vitamin D Deficiency, Asian