Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy

King Saud University

Status and phase: Completed; Phase 3

Conditions: Epilepsy; Vitamin D Deficiency

Treatments: Drug: Vitamin D 3

Study type: Interventional

Funder types: Other

Identifiers

NCT03536845

E-17-2425

Details and patient eligibility

About

To determine the maintenance dose of vitamin D supplementation required for children with epilepsy to maintain normal vitamin D level.

Full description

children aged 2-16 years diagnosed with idiopathic epilepsy will be randomized to receive either cholecalciferol doses (400IU vs 1000IU) with follow up at 3 and 6 months post supplementation.

Enrollment: 116 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children aged between 2-16 years who were diagnosed with Epilepsy and being treated with AEDs
2. Followed up in the outpatient pediatric neurology clinic at King Khalid University Hospital during the period of two years.

Exclusion criteria

1. Children with pre-existing vitamin D metabolism problems; because they are known to need different vitamin D doses and monitoring for clinical improvement:

   • Vitamin D dependent rickets
   • Malabsorption syndromes like celiac disease, inflammatory bowel disease
   • Renal disease
   • Hepatic disease

2. Children who are not safe to start vitamin D supplementation; because vitamin D supplementation will causes toxicity and induces nephrocalcinosis:

   • Hypercalcemia at baseline total corrected calcium >2.5mg/dl
   • Vitamin D level > 250 nmol/L
   • Urine calcium: creatinine ration > 1.2 mol/mol, or > 0.41g/g.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

400 IU

Active Comparator group

Treatment:

Drug: Vitamin D 3

1000 IU

Active Comparator group

Treatment:

Drug: Vitamin D 3