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

Inflammatory Bowel Disease (IBD) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256605
• Other study ID #: 524835
• Status: Completed
• Phase: N/A
• First received: October 1, 2014
• Last updated: May 28, 2015
• Start date: November 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: The Nemours Foundation
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammatory Bowel Disease (IBD)
• Inflammatory Bowel Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	NASPGHAN Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25 \(OH)D level will be recorded at baseline and at 8 weeks as an absolute value (ratio data) and the percentage and direction (increase or decrease) of change between baseline and end of treatment level.		8 weeks	No