Status:
COMPLETED
Vitamine D in Drug Resistant Epilepsy
Lead Sponsor:
Centre Hospitalier St Anne
Collaborating Sponsors:
APHP
FFRE
Conditions:
Drug Resistant Epilepsy
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
Almost all patients with epilepsy living in the region of Paris have vitamin D deficiency, which is severe in 1/3 of the cases. The impact of this deficiency on epilepsy is unknown, despite the sugges...
Detailed Description
The goal of this study is to establish the effect of the compensation of vitamin D deficiency in the treatment of drug-resistant epilepsy with a high level of evidence in a large population. For that,...
Eligibility Criteria
Inclusion
- Age\> 15 years
- Drug-resistant epilepsy (see definition above)
- Having at least 6 unprovoked seizures in the previous 3 months
- Epilepsy syndrome unequivocally established
- Ability to reliably quantify the seizure frequency
- Antiepileptic treatment stable for 3 months prior to inclusion
- No vitamin D treatment in the 6 months prior to inclusion vitamin D supplemental diet
- Medication compliance (confirmed by plasma levels if available)
- Agreeing to participate in the study
- Having a social insurance
- Parental agreement if patient below the age to be able to give consent (or guardian if protected adult)
Exclusion
- Progressive brain pathology
- Status epilepticus in the 2 years prior to inclusion,
- epilepsy surgery planned in the current year
- Pregnancy or breast-feeding
- Treatments influencing the metabolism of vitamin D other than anticoagulants (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil), leucovorin)
- Known hypersensitivity to vitamin D, patients with a history of granulomatosis (especially sarcoidosis)
- Contraindication to treatment with Uvedose referring to the summary of product characteristics
- Current or past hypercalcemia or situations accompanied by increased vulnerability to hypercalcemia as arrhythmia or digitalis therapy, subjects with calcium lithiasis
- Moderate renal impairment with creatinine clearance \<60 mL/mn assessed by MDRD (Modification of Diet in Renal Disease)
- Participation in other studies of other experimental drugs within 30 days before enrollment in the study
- Abuse of alcohol or drugs
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2020
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03475225
Start Date
April 3 2018
End Date
December 9 2020
Last Update
July 12 2024
Active Locations (2)
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1
Hôpital Kremlin Bicetre
Le Kremlin-Bicêtre, France, 94270
2
Centre Hospitalier Sainte Anne
Paris, France