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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536845
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
Dallah hospital
Information provided by (Responsible Party):
Reem Al Khalifah, King Saud University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 203 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 : January 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: 400 IU Drug: Vitamin D 3
oral drops

Active Comparator: 1000 IU Drug: Vitamin D 3
oral drops




Primary Outcome Measures :
  1. Vitamin D level < 75 nmol/L [ Time Frame: 6 months of supplementation ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536845


Contacts
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Contact: Reem Al Khalifah, MBBS, FRCps, Msc +96655710303 ralkahlifah@ksu.edu.sa

Locations
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Saudi Arabia
Reem ALKhalifah Recruiting
Riyadh, Saudi Arabia, 3134-13217
Contact: Reem ALKhalifah, MBBS    114690756    ralkhalifah@ksu.edu.sa   
Sub-Investigator: Fahad Bashiri, MBBS         
Sponsors and Collaborators
King Saud University
Dallah hospital
Investigators
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Principal Investigator: Reem Al Khalifah King Saud University
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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    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Vitamin D Deficiency
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents