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

• Sponsor: King Saud University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03536845
• Collaborator: Dallah hospital (Other)
• Enrollment: 116
• Location: 1
• Arms: 2
• Actual Duration (Months): 43
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Epilepsy; Vitamin D Deficiency	Drug: Vitamin D 3	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy: a Randomized Controlled Clinical Trial
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Aug 1, 2021
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 400 IU	Drug: Vitamin D 3; oral drops
Active Comparator: 1000 IU	Drug: Vitamin D 3; oral drops

Outcome Measures

Primary Outcome Measures

1. Vitamin D level < 75 nmol/L [6 months of supplementation]

Secondary Outcome Measures

1. Seizure rate [6 months of supplementation]

2. bone mineral density (BMD) measurement [6 months of supplementation]

3. 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

4. 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 Outcome Measures

1. Vitamin D level < 75 nmol/L [6 months of supplementation]

   subgroup analysis among enzyme inducer and non-enzyme inducer (anti-epileptic medications) AEDs

2. Vitamin D level < 75 nmol/L [6 months of supplementation]

   subgroup analysis among obese and non-obese patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts 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

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reem ALKhalifah	Riyadh		Saudi Arabia	3134-13217

Sponsors and Collaborators

• King Saud University
• Dallah hospital

Investigators

• Principal Investigator: Reem Al Khalifah, King Saud University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Reem Al Khalifah, Assistant Professor, King Saud University
• ClinicalTrials.gov Identifier: NCT03536845
• Other Study ID Numbers: E-17-2425
• First Posted: May 25, 2018
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epilepsy; Vitamin D Deficiency; Vitamin D; Cholecalciferol

Study Results

No Results Posted as of Sep 13, 2021