March 23, 2018

Vitamine D in Drug Resistant Epilepsy (EPI-D) Clinical Trial

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

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