Vitamin D Levels in Children With IBD

NCT00621257 | Terminated Results DMC

• 1 other identifier: 1K23DK076979-01A1
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Research has shown that children with Inflammatory Bowel Disease may have lower levels of vitamin D than healthy children, especially in the winter. Vitamin D is important for growing and maintaining healthy bones throughout life, and this is particularly important, since children with IBD frequently have low bone density. It may also be helpful in the treatment of IBD itself, because it helps reduce inflammation. Vitamin D levels are measured by the amount of 25 OHD in the blood; however, measuring this level on a regular basis is not yet the standard for children with IBD. The purpose of this study is to find the best way to treat low vitamin D levels, and to maintain good vitamin D levels throughout the year. It will also test whether having higher vitamin D levels will improve the bone health of children with IBD, and whether it will help them have milder disease.

Conditions

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Keywords

IBD; Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease

  Change in serum 25OHD levels after treatment with vitamin D formulations for 6 weeks in pediatric patients with inflammatory bowel disease. 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores.

  6 weeks

Secondary Outcomes (1)

• Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease

  12 months

Study Arms (5)

Treatment A

ACTIVE COMPARATOR

2,000 IU/day of ergocalciferol orally for 6 weeks (control arm)

Dietary Supplement: ergocalciferol

Treatment B

EXPERIMENTAL

2,000 IU/day of cholecalciferol orally for 6 weeks

Dietary Supplement: Cholecalciferol

Treatment C

EXPERIMENTAL

50,000 IU of ergocalciferol once a week orally for 6 weeks

Dietary Supplement: ergocalciferol

Maintenance A

ACTIVE COMPARATOR

400 IU/day of ergocalciferol orally over 2 years (control arm)

Dietary Supplement: ergocalciferol

Maintenance B

EXPERIMENTAL

2,000 IU/day of ergocalciferol orally from November 1 to April 30, and 1,000 IU/day of ergocalciferol orally for the remainder of the year over 2 years

Dietary Supplement: ergocalciferol

Interventions

ergocalciferol DIETARY_SUPPLEMENT

8000 units/ml

Also known as: Vitamin D2

Maintenance A; Maintenance B; Treatment A; Treatment C

Cholecalciferol DIETARY_SUPPLEMENT

400 units per drop

Also known as: Vitamin D3

Treatment B

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of inflammatory bowel disease
• serum 25OHD level ≤ 20 ng/mL (Treatment Trial)
• serum 25OHD level \> 20 ng/mL (Maintenance Trial)

You may not qualify if:

• Patients unable to take medications by mouth, pregnant, with liver/kidney failure, receiving anticonvulsant medications (specifically, phenobarbital, carbamazepine and phenytoin, since they lead to increased vitamin D metabolism through hepatic induction of the cytochrome P450 (CYP450) hydroxylase enzymes), regularly attending a tanning salon (once weekly or more), currently being treated for hypovitaminosis D with therapeutic doses of vitamin D (\> 800 IU per day) and unwilling to discontinue this regimen.
• patients on growth hormone, anabolic steroid hormones, calcitonin, bisphosphonates (Maintenance Trial only)

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Crohn's and Colitis Foundation: collaborator
• NASPGHAN Foundation: collaborator

Study Sites (1)

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Pappa HM, Mitchell PD, Jiang H, Kassiff S, Filip-Dhima R, DiFabio D, Quinn N, Lawton RC, Bronzwaer ME, Koenen M, Gordon CM. Maintenance of optimal vitamin D status in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing two regimens. J Clin Endocrinol Metab. 2014 Sep;99(9):3408-17. doi: 10.1210/jc.2013-4218. Epub 2014 Jun 13.

  PMID: 24926949 DERIVED

• Pappa HM, Mitchell PD, Jiang H, Kassiff S, Filip-Dhima R, DiFabio D, Quinn N, Lawton RC, Varvaris M, Van Straaten S, Gordon CM. Treatment of vitamin D insufficiency in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing three regimens. J Clin Endocrinol Metab. 2012 Jun;97(6):2134-42. doi: 10.1210/jc.2011-3182. Epub 2012 Mar 28.

  PMID: 22456619 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Ergocalciferols; Cholecalciferol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Helen Pappa, MD, MPH, Principal Investigator
• Organization: children's Hospital Boston

helen.pappa@childrens.harvard.edu

617-355-6058

Study Officials

• Helen Pappa, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 22, 2017
• Results First Posted: February 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)