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

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