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

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

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

Study Overview

• Status: Completed
• Conditions: Epilepsy; Vitamin D Deficiency
• Intervention / Treatment: Drug: Vitamin D 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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 3134-13217
    • Reem ALKhalifah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vitamin D level < 75 nmol/L	6 months of supplementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure rate		6 months of supplementation
bone mineral density (BMD) measurement		6 months of supplementation
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
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

Outcome Measure	Measure Description	Time Frame
Vitamin D level < 75 nmol/L	subgroup analysis among enzyme inducer and non-enzyme inducer (anti-epileptic medications) AEDs	6 months of supplementation
Vitamin D level < 75 nmol/L	subgroup analysis among obese and non-obese patients	6 months of supplementation

Collaborators and Investigators

• Sponsor: King Saud University
• Collaborators: Dallah hospital
• Investigators: Principal Investigator: Reem Al Khalifah, King Saud University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Epilepsy; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: E-17-2425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No