The effect of vitamin D on epilepsy

• Conditions: Epilepsy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-001826-84-HU
• Lead Sponsor: niversity of Pécs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-10
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

pharmacoresistancy
age: > 18 years
serum level of 25(OH)D < 30ng/ml
quantifiable seizures
seizure diary tracked for a minimum of 3 months before entering the trial

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

presence of psychogenic seizures
pregnancy, lactation
impaired kidney function
history of sarcoidosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine the effect of vitamin D3 in epilepsy patients;Secondary Objective: To examine the effect of vitamin D3 on psychometric parameters;Primary end point(s): change in seizure frequency;Timepoint(s) of evaluation of this end point: Time intervals for the first and second 4 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): change in the psycometric parameters;Timepoint(s) of evaluation of this end point: Time intervals for the first and second 4 months