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

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ClinicalTrials.gov Identifier: NCT02890823
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Cholecalciferol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016


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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number (percentage) of the patients who have serum 25-hydroxyvitamin D levels more than 30ng/ml [ Time Frame: 16 months ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02890823     History of Changes
Other Study ID Numbers: RA58/075
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Keywords provided by Chulalongkorn University:
Antiepileptic Drugs
Vitamin D Deficiency
Asian
Additional relevant MeSH terms:
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Rickets
Epilepsy
Avitaminosis
Vitamin D Deficiency
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D
Cholecalciferol
Hydroxycholecalciferols
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents