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Chassoux, Francine; Navarro, Vincent; Quirins, Marion; Laurent, Agathe; Gavaret, Martine; Cousyn, Louis; Crépon, Benoit; Landré, Elisabeth; Marchi, Angela; Soufflet, Christine; Rusu‐Devaux, Violeta; Mancusi, Rossella Letizia; Piketty, Marie‐Liesse; Souberbielle, Jean‐Claude

Vitamin D deficiency and effect of treatment on seizure frequency and quality of life parameters in patients with drug‐resistant epilepsy: A randomized clinical trial

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  • Media type: E-Article
  • Title: Vitamin D deficiency and effect of treatment on seizure frequency and quality of life parameters in patients with drug‐resistant epilepsy: A randomized clinical trial
  • Contributor: Chassoux, Francine; Navarro, Vincent; Quirins, Marion; Laurent, Agathe; Gavaret, Martine; Cousyn, Louis; Crépon, Benoit; Landré, Elisabeth; Marchi, Angela; Soufflet, Christine; Rusu‐Devaux, Violeta; Mancusi, Rossella Letizia; Piketty, Marie‐Liesse; Souberbielle, Jean‐Claude
  • Published: Wiley, 2024
  • Published in: Epilepsia (2024)
  • Language: English
  • DOI: 10.1111/epi.18050
  • ISSN: 1528-1167; 0013-9580
  • Origination:
  • Footnote:
  • Description: AbstractObjectiveThis study was undertaken to assess the effect of treatment of vitamin D deficiency in drug‐resistant epilepsy.MethodsWe conducted a multicenter, double‐blind, placebo‐controlled, randomized clinical trial, including patients aged ≥15 years with drug‐resistant focal or generalized epilepsy. Patients with 25‐hydroxyvitamin D (25[OH]D) < 30 ng/mL were randomized to an experimental group (EG) receiving vitamin D3 (cholecalciferol, 100 000 IU, five doses in 3 months) or a control group (CG) receiving matched placebo. During the open‐label study, EG patients received 100 000 IU/month for 6 months, whereas CG patients received five doses in 3 months then 1/month for 3 months. Monitoring included seizure frequency (SF), 25(OH)D, calcium, albumin, creatinine assays, and standardized scales for fatigue, anxiety–depression, and quality of life (Modified Fatigue Impact Scale [M‐FIS], Hospital Anxiety and Depression Scale, Quality of Life in Epilepsy [QOLIE‐31]) at 3, 6, and 12 months. The primary efficacy outcome was the percentage of SF reduction compared to the reference period and CG at 3 months. Secondary outcomes were SF and bilateral tonic–clonic seizure (BTCS) reduction, scale score changes, and correlations with 25(OH)D during the follow‐up.ResultsEighty‐eight patients were enrolled in the study (56 females, aged 17–74 years), with median baseline SF per 3 months = 16.5 and ≥2 antiseizure medications in 88.6%. In 75 patients (85%), 25(OH)D was <30 ng/mL; 40 of them were randomly assigned to EG and 34 to CG. After the 3‐month blinded period, SF reduction did not significantly differ between groups. However, during the open‐label period, SF significantly decreased (30% median SF reduction, 33% responder rate at 12 months). BTCSs were reduced by 52%. M‐FIS and QOLIE‐31 scores were significantly improved at the whole group level. SF reduction correlated with 25(OH)D > 30 ng/mL for >6 months.SignificanceDespite no proven effect after the 3‐month blinded period, the open‐label study suggests that long‐term vitamin D3 supplementation with optimal 25(OH)D may reduce SF and BTCSs, with a positive effect on fatigue and quality of life. These findings need to be confirmed by further long‐term studies.Trial RegistrationClinicalTrials.gov identifier: NCT03475225 (03‐22‐2018).