NCT02076750

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

December 11, 2013

Last Update Submit

November 25, 2014

Conditions

Inflammatory Bowel DiseasesSkin Pigmentation

Keywords

Inflammatory Bowel DiseasesVitamin DCholecalciferolSkin Pigmentation

Outcome Measures

Primary Outcomes (1)

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

    Weeks 0, 8 and 12 of study.

Secondary Outcomes (2)

  • Change from baseline serum calcium level at 8 and 12 weeks

    Weeks 0, 8 and 12 of study.

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

    Weeks 0, 8 and 12 of study

Study Arms (2)

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

EXPERIMENTAL

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)

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

ACTIVE COMPARATOR

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)

Interventions

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

Eligibility Criteria

Age8 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Healthcare of Atlanta, Egleston Children's Hospital

Atlanta, Georgia, 30322, United States

Location

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

  • 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.

    PMID: 22924607BACKGROUND

  • 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.

    PMID: 21694532BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel DiseasesPigmentation Disorders

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Subra Kugathasan, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2013

First Posted

March 4, 2014

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations

US(2)