Vitamin D supplementation to prevent vitamin D deficiency for children with epilepsy: Randomized pragmatic trial...

Area of Science:

• Pediatric Neurology
• Endocrinology
• Clinical Trials

Background:

• Vitamin D deficiency is common in children with epilepsy, impacting treatment recommendations.
• Existing evidence is insufficient to guide optimal vitamin D supplementation strategies.
• This study addresses the need for evidence-based guidelines for vitamin D in pediatric epilepsy.

Purpose of the Study:

• To compare the efficacy of 400 IU/day versus 1000 IU/day of Cholecalciferol in maintaining optimal 25-hydroxy vitamin D levels in children with epilepsy.
• To assess the impact of different vitamin D doses on seizure control and bone health.
• To inform updated clinical guidelines for vitamin D supplementation in pediatric epilepsy.

Main Methods:

• Phase IV pragmatic, randomized, superiority controlled, open-label trial.
• Participants: Children with epilepsy on antiepileptic medication with normal baseline vitamin D levels.
• Intervention: Cholecalciferol 400 IU/day vs. 1000 IU/day for 6 months.

Main Results:

• Primary outcome: Proportion of children with vitamin D insufficiency (25 [OH] vitamin D < 75 nmol/L) at 6 months.
• Secondary outcomes: Seizure treatment failure, seizure frequency, parathyroid hormone levels, bone mineral density, and safety.
• Data analysis will determine the superiority of one dose over the other in maintaining vitamin D sufficiency.

Conclusions:

• The study will evaluate the effectiveness of common vitamin D maintenance doses on vitamin D levels, seizure control, and bone health in epileptic children.
• Results may influence current vitamin D supplementation guidelines for this population.
• Potential to establish a link between 25-hydroxy vitamin D levels and seizure control efficacy.