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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001019-35-FR

Enrollment

400

Registered

2018-01-17

Start date

2017-12-19

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients suffering from drug-resistant epilepsy.

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Epilepsy surgery scheduled within 12 months - Status of epilepticus in the 2 years preceding the study - Treatments influencing the metabolism of vitamin D other than anticoagulants - Contra-indication to treatment with Uvédose - Moderate renal impairment.

Design outcomes

Primary

Measure	Time frame
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.;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.;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.	—

Measure

Time frame

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.;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.;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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

France

Contacts

Public ContactDOROCANT Sylvie

Centre Hospitalier Sainte-Anne

s.dorocant@ch-sainte-anne.fr330145657728

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026