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CompletedNCT02890823Updated Sep 7, 2016

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

A Phase 4 interventional study of Cholecalciferol in Epilepsy, sponsored by Chulalongkorn University. Completed. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2016-09-07.

Sponsored by Chulalongkorn University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Epilepsy

Keywords

  • Antiepileptic Drugs
  • Vitamin D Deficiency
  • Asian
03

In context

Rickets

92 studies on the registry are indexed under Rickets; 5 are open to participants now.

This study's enrollment of 210 is above the median of 53 across 62 interventional studies indexed under Rickets.

Browse Rickets studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with a history of hypercalcemia, nephrolithiasis, fractures, hepatic disease, kidney disease, granulomatous disease or currently supplemented with vitamin D.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
210 participants (actual)

Study arms

  • 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

Interventions

  • DrugCholecalciferol
06

What researchers measure

Primary outcomes

  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 outcomes

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

    Time frame: 16 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02890823
Lead sponsor
Chulalongkorn University
Responsible party
Sponsor
First posted
Sep 7, 2016
Start date
Jul 2015
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Sep 7, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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