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Completed

NCT Number: NCT03536845

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

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

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Key information

Conditions

Epilepsy Avitaminosis Brain Diseases Central Nervous System Diseases Deficiency Diseases Malnutrition Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Reem ALKhalifah

Riyadh, 3134-13217, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Vitamin D 3

Drug

oral drops

Primary outcomes

  1. Vitamin D level < 75 nmol/L

    Time frame: 6 months of supplementation

Secondary outcomes

  1. Seizure rate

    Time frame: 6 months of supplementation

  2. bone mineral density (BMD) measurement

    Time frame: 6 months of supplementation

  3. Cost- effectiveness of vitamin D supplementation

    Time frame: 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.

    Time frame: 6 months of supplementation

Other outcomes

  1. Vitamin D level < 75 nmol/L

    Time frame: 6 months of supplementation

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

  2. Vitamin D level < 75 nmol/L

    Time frame: 6 months of supplementation

    subgroup analysis among obese and non-obese patients

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Collaborators

  • Dallah hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 25, 2018
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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