Epilepsy, Vitamin D Deficiency
Conditions
Brief summary
To determine the maintenance dose of vitamin D supplementation required for children with epilepsy to maintain normal vitamin D level.
Detailed 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.
Interventions
DRUGVitamin D 3
oral drops
Sponsors
Dallah hospital
King Saud University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vitamin D level < 75 nmol/L | 6 months of supplementation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seizure rate | 6 months of supplementation | — |
| bone mineral density (BMD) measurement | 6 months of supplementation | — |
| Cost- effectiveness of vitamin D supplementation | 6 months of supplementation | cost of vitamin D supplementation compared to the cost of poor bone health, hospital admission |
| Safety: Prevalence of hypercalcemia total calcium >2.7mg/dl, 25 OH vit D level> 250 nmol/l, and Urine calcium: creatinine ration > 1.2 mol/mol, or > 0.41g/g. | 6 months of supplementation | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D level < 75 nmol/L | 6 months of supplementation | subgroup analysis among enzyme inducer and non-enzyme inducer (anti-epileptic medications) AEDs |
Countries
Saudi Arabia
Outcome results
None listed