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Weekly Vitamin D in Pediatric IBD

Primary Purpose

Inflammatory Bowel Diseases, Skin Pigmentation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3 (cholecalciferol)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Inflammatory Bowel Diseases, Vitamin D, Cholecalciferol, Skin Pigmentation

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Healthcare of Atlanta, Egleston Children's Hospital
  • Emory Children's Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin D3 (cholecalciferol) 10,000 IU per 10 kg body weight

Vitamin D3 (cholecalciferol) 5,000 IU per 10 kg body weight

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline serum 25-OH vitamin D level at 8 and 12 weeks

Secondary Outcome Measures

Change from baseline serum calcium level at 8 and 12 weeks
Change from baseline serum parathyroid hormone level at 8 and 12 weeks

Full Information

First Posted
December 11, 2013
Last Updated
November 25, 2014
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02076750
Brief Title
Weekly Vitamin D in Pediatric IBD
Official Title
Weekly Vitamin D3 for Treatment of Hypovitaminosis D in Children and Adolescents With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Skin Pigmentation
Keywords
Inflammatory Bowel Diseases, Vitamin D, Cholecalciferol, Skin Pigmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3 (cholecalciferol) 10,000 IU per 10 kg body weight
Arm Type
Experimental
Arm Description
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.
Arm Title
Vitamin D3 (cholecalciferol) 5,000 IU per 10 kg body weight
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 (cholecalciferol)
Primary Outcome Measure Information:
Title
Change from baseline serum 25-OH vitamin D level at 8 and 12 weeks
Time Frame
Weeks 0, 8 and 12 of study.
Secondary Outcome Measure Information:
Title
Change from baseline serum calcium level at 8 and 12 weeks
Time Frame
Weeks 0, 8 and 12 of study.
Title
Change from baseline serum parathyroid hormone level at 8 and 12 weeks
Time Frame
Weeks 0, 8 and 12 of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established diagnosis of inflammatory bowel disease made by a pediatric gastroenterologist and confirmed by histopathology Serum 25-OH vitamin D level <30 ng/mL at time of enrollment. Age 8-21 years Weight > 20 kg Parent, guardian, or subject (where applicable) able to give consent/assent Exclusion Criteria: Inability to ingest oral vitamin D3 capsules Presence of known hepatobiliary disease Presence of known kidney disease or history of renal stones Use of systemic steroids within 60 days prior to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subra Kugathasan, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta, Egleston Children's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22924607
Citation
Osunkwo I, Ziegler TR, Alvarez J, McCracken C, Cherry K, Osunkwo CE, Ofori-Acquah SF, Ghosh S, Ogunbobode A, Rhodes J, Eckman JR, Dampier C, Tangpricha V. High dose vitamin D therapy for chronic pain in children and adolescents with sickle cell disease: results of a randomized double blind pilot study. Br J Haematol. 2012 Oct;159(2):211-5. doi: 10.1111/bjh.12019. Epub 2012 Aug 28.
Results Reference
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PubMed Identifier
21694532
Citation
Pappa H, Thayu M, Sylvester F, Leonard M, Zemel B, Gordon C. Skeletal health of children and adolescents with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2011 Jul;53(1):11-25. doi: 10.1097/MPG.0b013e31821988a3. Erratum In: J Pediatr Gastroenterol Nutr. 2012 Apr;54(4):571.
Results Reference
background

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Weekly Vitamin D in Pediatric IBD

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