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
propose a multicentre placebo controlled randomized double-blind study, testing vitamin D
supplementation against placebo in 400 drug-resistant patients to assess the short-term (3
months) and long-term (1 year) benefits on epilepsy. 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. The impact on the care of
patients is important because better epilepsy control allows reduction of the antiepileptic
drugs and side effects. This again is a key for the recovery of social and professional
activities, and reduction of costs related to the disease.
Phase:
Phase 3
Details
Lead Sponsor:
Centre Hospitalier St Anne
Collaborators:
APHP FFRE LFCE
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins