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

NCT03536845 | Completed Phase 3

• 1 other identifier: E-17-2425
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Vitamin D level < 75 nmol/L

  6 months of supplementation

Secondary Outcomes (4)

• 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

• 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 Outcomes (2)

• Vitamin D level < 75 nmol/L

  6 months of supplementation

• Vitamin D level < 75 nmol/L

  6 months of supplementation

Study Arms (2)

400 IU

ACTIVE COMPARATOR

Drug: Vitamin D 3

1000 IU

ACTIVE COMPARATOR

Drug: Vitamin D 3

Interventions

Vitamin D 3 DRUG

oral drops

1000 IU; 400 IU

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• King Saud University: lead
• Dallah hospital: collaborator

Study Sites (1)

Reem ALKhalifah

Riyadh, 3134-13217, Saudi Arabia

Location

MeSH Terms

Conditions

Epilepsy; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Reem Al Khalifah

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 25, 2018
• Study Start: January 1, 2018
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

SA (1)