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

Primary Purpose

Epilepsy, Vitamin D Deficiency

Status

Completed

Phase

Phase 3

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Vitamin D 3

About this trial

This is an interventional prevention trial for Epilepsy

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Reem ALKhalifah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

400 IU

1000 IU

Arm Description

Outcomes

Primary Outcome Measures

Vitamin D level < 75 nmol/L

Secondary Outcome Measures

Seizure rate

bone mineral density (BMD) measurement

Cost- effectiveness of vitamin D supplementation

cost of vitamin D supplementation compared to the cost of poor bone health, hospital admission

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.

Full Information

NCT ID

NCT03536845

First Posted

May 14, 2018

Last Updated

September 3, 2021

Sponsor

King Saud University

Collaborators

Dallah hospital

1. Study Identification

Unique Protocol Identification Number

NCT03536845

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

August 1, 2021 (Actual)

Study Completion Date

August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Saud University

Collaborators

Dallah hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Vitamin D Deficiency

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

400 IU

Arm Type

Active Comparator

Arm Title

1000 IU

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Vitamin D 3

Intervention Description

oral drops

Primary Outcome Measure Information:

Title

Vitamin D level < 75 nmol/L

Time Frame

6 months of supplementation

Secondary Outcome Measure Information:

Title

Seizure rate

Time Frame

6 months of supplementation

Title

bone mineral density (BMD) measurement

Time Frame

6 months of supplementation

Title

Cost- effectiveness of vitamin D supplementation

Description

cost of vitamin D supplementation compared to the cost of poor bone health, hospital admission

Time Frame

6 months of supplementation

Title

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 Pre-specified Outcome Measures:

Title

Vitamin D level < 75 nmol/L

Description

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

Time Frame

6 months of supplementation

Title

Vitamin D level < 75 nmol/L

Description

subgroup analysis among obese and non-obese patients

Time Frame

6 months of supplementation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reem Al Khalifah

Organizational Affiliation

King Saud University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Reem ALKhalifah

City

Riyadh

ZIP/Postal Code

3134-13217

Country

Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing URL

https://journals.lww.com/md-journal/Fulltext/2018/10050/Vitamin_D_supplementation_to_prevent_vitamin_D.99.aspx

Learn more about this trial

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

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