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

September 6, 2016 updated by: Chulalongkorn University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 8 and 16 months
8 and 16 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA58/075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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