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

NCT02256605 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2015-05-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • NASPGHAN Foundation

    collaborator OTHER_GOV

  • Nemours Children's Clinic

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02256605 on ClinicalTrials.gov