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 suggested benefits of vitamin D therapy including better seizure control and improvement of comorbidities (fatigue, anxiety, depression) in drug-resistant patients. Recommendations for vitamin D supplementation based on the serum level in the general population cannot be applied to patients with epilepsy due to interference of antiepileptic drugs in the vitamin D metabolism. Animal models, mechanisms of action studies and ecological information provide objective data for a direct antiepileptic effect of vitamin D. Human studies seem to confirm the antiepileptic effect of vitamin D but there are no controlled studies on large populations.
The investigators aim to assess prospectively the effect of the treatment of vitamin D deficiency providing a high level of evidence. The investigators hypothesize that the treatment of vitamin D deficiency will result in significant reduction of seizure frequency, and improvement of comorbid symptoms as well as quality of life.
Anticipated Study Start Date: April 2018
Estimated Study Completion Date: April 2020
Eligibility Criteria
Ages Eligible for Study: 15 Years and older (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria
- 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 Criteria
- 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 (rifamicin, isoniazid, ketoconazole, 5-FU, 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
- Participation in other studies of other experimental drugs within 30 days before enrollment in the study
- Abuse of alcohol or drugs