Vitamin D3 Supplementation in Pediatric IBD: Weely vs Daily Dosing Regimens

Nemours Children's Health

Status

Completed

Conditions

Inflammatory Bowel Disease (IBD)

Treatments

Dietary Supplement: Vitamin D-3

Study type

Observational

Funder types

Other

Identifiers

NCT02256605

524835

Details and patient eligibility

About

The purpose of this prospecitve randomized controlled trial is to compare effectiveness and patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D [25(OH)D] insufficient or deficient. The primary aim of this pilot study is to evaluate the effectiveness of once weekly verses daily D-3 dosing regimens based on the most current IBD supplementation guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is difference in adherence between dosing regimns.

Enrollment

40 estimated patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects aged 5 to 17 years with a diagnosis of Inflammatory Bowel Disease, who have a 25(OH)D level below 30 ng/ml within 2 weeks of enrollment
Subject/family must be able and willing to take oral medications, complete a 3 day dietary record, and return for 8 week concluding visit or clinicl visit

Exclusion criteria

Subjects will not be eligible if they are intolerant of vitamin supplementation or any ingredients in the chosen supplment, are unable or unwilling to take oral supplements, or are on specific medical therapy for diminished bone mineral density
Children with parathryoid disease, granulomatous disorders or William's syndrome will also be excluded from the study