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

Epilepsy Clinical Trial

Official title:

Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536845
• Other study ID #: E-17-2425
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2021
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D 3
oral drops

Locations

Country	Name	City	State
Saudi Arabia	Reem ALKhalifah	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King Saud University	Dallah hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vitamin D level < 75 nmol/L	subgroup analysis among enzyme inducer and non-enzyme inducer (anti-epileptic medications) AEDs	6 months of supplementation
Other	Vitamin D level < 75 nmol/L	subgroup analysis among obese and non-obese patients	6 months of supplementation
Primary	Vitamin D level < 75 nmol/L		6 months of supplementation
Secondary	Seizure rate		6 months of supplementation
Secondary	bone mineral density (BMD) measurement		6 months of supplementation
Secondary	Cost- effectiveness of vitamin D supplementation	cost of vitamin D supplementation compared to the cost of poor bone health, hospital admission	6 months of supplementation
Secondary	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