NCT02256605

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Inflammatory Bowel Disease (IBD)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D-3	Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a routine clinic visit or lab draw that included a 25(OH)D level as part of clinical practice/standard care. Once consent and assent are obtained, the children who are 25-hydroxyvitamin D \[259OH)D\] insufficient or deficient will be randomly assigned to a daily or weekly dosing regimen using block randomization to ensure equal group size.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-10-03
• Last updated: 2015-05-29

Locations

1 site across 1 country: United States