Effect of vitamin D deficiency compensation in the treatment of drug-resistant epilepsy.

INTERVENTION: Trade Name: UVEDOSE 100 000 UI Product Name: UVEDOSE Pharmaceutical Form: Oral liquid Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use CONDITION: Patients suffering from drug‐resistant epilepsy. Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To evaluate the effect of vitamin D deficiency compensation on the frequency of crises in patients over 15 years of age following drug‐resistant epilepsy, the percentage reduction in the number of crises after 3 months of deficit compensation In vitamin D compared to the reference period and the control group. Primary end point(s): Percentage of reduction in the number of crises after 3 months of compensation for vitamin D deficiency in relation to the reference period and the control group. Secondary Objective: 1) Evaluate the effect of vitamin D deficiency compensation on comorbidities, quality of life, anxiety and depression at baseline, 3 months, 6 months, and 12 months using standardized scales;; ; 2) Look for a significant association between serum vitamin D levels and decreased crises frequency in vitamin D substitutes;; ; 3) Analyze the serum level of vitamin D at baseline as a function of antiepileptics monotherapy or in combination;; ; 4) To evaluate the rate of patients responding and in remission under vitamin D supplementation and remission at 3, 6 and 12 months;; ; 5) Evaluate the effectiveness of vitamin D deficiency compensation for epileptic syndrome after 3, 6 and 9 months of vitamin D supplementation;; ; 6) To evaluate the efficacy of the vitamin D deficiency compensation according to the severity of crises after 3, 6 and 9 months of vitamin D supplementation. SECONDARY OUTCOME: Secondary end point(s): 1) Fatigue, anxiety and depression scores and quality of life at baseline, 3 months, 6 months and 12 months; ; ; 2) Serum vitamin D assays at baseline, 3 months, 6 months, 12 months and percentage reduction in the number of crises over the last 3 months of treatment compared to the reference period. ; ; 3) Serum vitamin D assays at baseline and type of antiepileptic treatment given; ; ; 4) Rate of responders and remission at 3, 6 and 12 months; ; ; 5) Rate of responders in focal and generalized epilepsy groups after 3, 6 and 9 months of vitamin D supplementation. ; ; 6) Number of generalized tonic‐clonic crises and / or crises with falls in patients with this type of crises, after 3, 6 and 9 months of vitamin D supplementation, compared to the reference period. INCLUSION CRITERIA: ‐ Age> 15 years ‐ At least 6 unprovoked crises in the 3 months prior to inclusion ‐ Syndromic diagnosis of established epilepsy ‐ Stable antiepileptic treatment during the 3 months prior to inclusion ‐ Absence of vitamin D treatment in the 6 months prior to inclusion. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150