Weekly Vitamin D in Pediatric IBD

November 25, 2014 updated by: Subra Kugathasan, MD, Emory University

Weekly Vitamin D3 for Treatment of Hypovitaminosis D in Children and Adolescents With Inflammatory Bowel Disease

The purpose of this study is to determine whether weekly dosing of oral vitamin D3 is effective in correcting low vitamin D levels in children and adolescents with inflammatory bowel disease (also known as Crohn's disease and ulcerative colitis).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The role of vitamin D in skeletal health is well established. More recently, vitamin D has been implicated in multiple other disease states and is currently a topic of much discussion in the pediatric and adult medical literature. Individuals with gastrointestinal or hepatobiliary diseases that limit the absorption of dietary vitamin D and those individuals with limited sunlight exposure or darker skin color are at risk for suboptimal vitamin D status. Recent joint guidelines from the North American and European Societies of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN and ESPGHAN, respectively) have recommended routine surveillance and treatment for vitamin D insufficiency/deficiency in children affected by inflammatory bowel diseases (IBD), namely Crohn's disease (CD) and ulcerative colitis (UC). Current recommendations are for prolonged daily dosing of oral vitamin D, but studies in children with other chronic diseases have demonstrated the benefit of improved compliance with less frequent, higher doses of vitamin D. The primary goal of this pilot study is to establish whether weekly dosing of vitamin D can correct suboptimal vitamin D status in children with inflammatory bowel disease. A secondary goal is to evaluate whether pediatric IBD patients with darker skin respond differently to vitamin D therapy than do their lighter-skinned counterparts.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Children's Center
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta, Egleston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Established diagnosis of inflammatory bowel disease made by a pediatric gastroenterologist and confirmed by histopathology
  2. Serum 25-OH vitamin D level <30 ng/mL at time of enrollment.
  3. Age 8-21 years
  4. Weight > 20 kg
  5. Parent, guardian, or subject (where applicable) able to give consent/assent

Exclusion Criteria:

  1. Inability to ingest oral vitamin D3 capsules
  2. Presence of known hepatobiliary disease
  3. Presence of known kidney disease or history of renal stones
  4. Use of systemic steroids within 60 days prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vitamin D3 (cholecalciferol) 10,000 IU per 10 kg body weight
Vitamin D3 (cholecalciferol) will be administered orally at a dose of 10,000 IU per 10 kg body weight weekly for 6 consecutive weeks. The maximum dose will be 50,000 IU weekly for patients weighing 50 kg or greater.
Dietary supplement: Vitamin D3 (cholecalciferol)
ACTIVE_COMPARATOR: Vitamin D3 (cholecalciferol) 5,000 IU per 10 kg body weight
Vitamin D3 (cholecalciferol) will be administered orally at a dose of 5,000 IU per 10 kg body weight weekly for 6 consecutive weeks. The maximum dose will be 25,000 IU weekly for patients weighing 50 kg or greater.
Dietary supplement: Vitamin D3 (cholecalciferol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline serum 25-OH vitamin D level at 8 and 12 weeks
Time Frame: Weeks 0, 8 and 12 of study.
Weeks 0, 8 and 12 of study.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline serum calcium level at 8 and 12 weeks
Time Frame: Weeks 0, 8 and 12 of study.
Weeks 0, 8 and 12 of study.
Change from baseline serum parathyroid hormone level at 8 and 12 weeks
Time Frame: Weeks 0, 8 and 12 of study
Weeks 0, 8 and 12 of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

March 3, 2014

First Posted (ESTIMATE)

March 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 26, 2014

Last Update Submitted That Met QC Criteria

November 25, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00061627

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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