NCT02890823

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

September 1, 2016

Last Update Submit

September 6, 2016

Conditions

Epilepsy

Keywords

Antiepileptic DrugsVitamin D DeficiencyAsian

Outcome Measures

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

    8 and 16 months

Secondary Outcomes (1)

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

    16 months

Study Arms (6)

EIAEDs-1000

EXPERIMENTAL

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

Drug: Cholecalciferol

EIAEDs-3000

EXPERIMENTAL

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

Drug: Cholecalciferol

EIAEDs-6000

EXPERIMENTAL

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

Drug: Cholecalciferol

non-EIAEDs-1000

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

non-EIAEDs-3000

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

non-EIAEDs-6000

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

Interventions

CholecalciferolDRUG
EIAEDs-1000EIAEDs-3000EIAEDs-6000non-EIAEDs-1000non-EIAEDs-3000non-EIAEDs-6000

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EpilepsyVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 7, 2016

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09