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

C

Chulalongkorn University

Status and phase

Completed
Phase 4

Conditions

Epilepsy

Treatments

Drug: Cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT02890823
RA58/075

Details and patient eligibility

About

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.

Full 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.

Enrollment

210 patients

Sex

All

Ages

15+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

210 participants in 6 patient groups

EIAEDs-1000
Experimental group
Description:
Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily
Treatment:
Drug: Cholecalciferol
EIAEDs-3000
Experimental group
Description:
Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily
Treatment:
Drug: Cholecalciferol
EIAEDs-6000
Experimental group
Description:
Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily
Treatment:
Drug: Cholecalciferol
non-EIAEDs-1000
Active Comparator group
Description:
Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily
Treatment:
Drug: Cholecalciferol
non-EIAEDs-3000
Active Comparator group
Description:
Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily
Treatment:
Drug: Cholecalciferol
non-EIAEDs-6000
Active Comparator group
Description:
Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily
Treatment:
Drug: Cholecalciferol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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