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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Antiepileptic Drugs, Vitamin D Deficiency, Asian

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    EIAEDs-1000

    EIAEDs-3000

    EIAEDs-6000

    non-EIAEDs-1000

    non-EIAEDs-3000

    non-EIAEDs-6000

    Arm Description

    Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily

    Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily

    Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily

    Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily

    Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily

    Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 1, 2016
    Last Updated
    September 6, 2016
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02890823
    Brief Title
    Effect of Three Different Doses of Oral Cholecalciferol on 25-Hydroxyvitamin D Changes Among Epilepsy Patients With Hypovitaminosis D
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy
    Keywords
    Antiepileptic Drugs, Vitamin D Deficiency, Asian

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    210 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EIAEDs-1000
    Arm Type
    Experimental
    Arm Description
    Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily
    Arm Title
    EIAEDs-3000
    Arm Type
    Experimental
    Arm Description
    Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily
    Arm Title
    EIAEDs-6000
    Arm Type
    Experimental
    Arm Description
    Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily
    Arm Title
    non-EIAEDs-1000
    Arm Type
    Active Comparator
    Arm Description
    Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily
    Arm Title
    non-EIAEDs-3000
    Arm Type
    Active Comparator
    Arm Description
    Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily
    Arm Title
    non-EIAEDs-6000
    Arm Type
    Active Comparator
    Arm Description
    Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Cholecalciferol
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Number (percentage) of the patients who have serum 25-hydroxyvitamin D levels more than 30ng/ml
    Time Frame
    16 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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