Vitamine D in Drug Resistant Epilepsy

NCT03475225 | Completed Phase 3

• 1 other identifier: D16-P15
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Drug Resistant Epilepsy

Keywords

Epilepsy; Drug-resistance; Vitamin D deficiency; Metabolism; Controlled study antiepileptic drugs

Outcome Measures

Primary Outcomes (1)

• Percentage reduction of the seizure frequency

  With respect to the reference period

  After 3 months of treatment of vitamin D deficiency

Secondary Outcomes (10)

• Effect on Fatigue scores : Modified Fatigue Impact Scale (M-FIS)

  3, 6 and 12 months

• Effect anxiety-depression : Hospital anxiety depression scale (HAD)

  3, 6 and 12 months

• Quality of Life in Epilepsy: (QOLIE 31) including 7 subscores: global score calculated on the basis on the mean of each subscore

  3, 6 and 12 months

• Relationship between serum vitamin D levels and seizure frequency reduction after vitamin D treatment

  3, 6 and 12 months

• Relationship between serum vitamin D levels and seizure frequency reduction after vitamin D treatment

  3, 6 and 12 months.

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Drug resistant epilepsy patients with proved Vitamin D deficiency (Serum vitamin D level \<30ng/ml) Cholecalciferol. 5 doses of cholecalciferol (100 000 IU) in 3 months than 1 dose of cholecalciferol (100 000 IU) per month during 6 months

Drug: Cholecalciferol

Control Arm

PLACEBO COMPARATOR

Drug resistant epilepsy patients with proved Vitamin D deficiency (Serum vitamin D level\<30ng/ml) Placebo than cholecalciferol. 5 doses of placebo in 3 months than 5 doses of cholecalciferol (100 000 IU) in 3 months than 1 dose of cholecalciferol (100 000 IU) per month during 3 months.

Drug: Placebo Oral

Interventions

Cholecalciferol DRUG

Cholecalciferol delivery

Experimental Arm

Placebo Oral DRUG

manufactured to mimic Cholecalciferol

Control Arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• Progressive brain pathology
• epilepsy surgery planned in the current year
• Pregnancy or breast-feeding
• Treatments influencing the metabolism of vitamin D other than anticoagulants (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil), 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 (Modification of Diet in Renal Disease)
• Participation in other studies of other experimental drugs within 30 days before enrollment in the study
• Abuse of alcohol or drugs

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead
• APHP: collaborator
• FFRE: collaborator
• LFCE: collaborator

Study Sites (2)

Hôpital Kremlin Bicetre

Le Kremlin-Bicêtre, 94270, France

Location

Centre Hospitalier Sainte Anne

Paris, France

Location

Related Publications (52)

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MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• CHASSOUX Francine, MD

  Centre Hospitalier Sainte-Anne - 1, rue Cabanis 75014 Paris FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: March 23, 2018
• Study Start: April 3, 2018
• Primary Completion: March 4, 2020
• Study Completion: December 9, 2020
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

FR (2)