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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-08-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Epilepsy Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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400 IU

Group Type ACTIVE_COMPARATOR

Vitamin D 3

Intervention Type DRUG

oral drops

1000 IU

Group Type ACTIVE_COMPARATOR

Vitamin D 3

Intervention Type DRUG

oral drops

Interventions

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Vitamin D 3

oral drops

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No