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| Sponsors and Collaborators: |
Children's Hospital Boston National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Crohn's and Colitis Foundation North American Society of Pediatric Gastroenterology, Hepatology and Nutrition |
|---|---|
| Information provided by: | Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT00621257 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis |
Dietary Supplement: ergocalciferol Dietary Supplement: Cholecalciferol |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD. |
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment A: Active Comparator
2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)
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Dietary Supplement: ergocalciferol
8000 units/ml
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Treatment B: Active Comparator
2,000 IU/day of vitamin D3 orally for 6 weeks
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Dietary Supplement: Cholecalciferol
400 units per drop
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Treatment C: Active Comparator
50,000 IU of vitamin D2 once a week orally for 6 weeks
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Dietary Supplement: ergocalciferol
8000 units/ml
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Maintenance A: Active Comparator
400 IU/day of vitamin D2 orally over 2 years (control arm)
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Dietary Supplement: ergocalciferol
8000 units/ml
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Maintenance B: Active Comparator
2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years
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Dietary Supplement: ergocalciferol
8000 units/ml
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Vitamin D is essential for bone mineralization. The prevalence of vitamin D insufficiency [serum 25-hydroxy-vitamin D concentration (25OHD) ≤ 20 ng/mL] is high among adults with inflammatory bowel disease (IBD), and even higher in pediatric patients with IBD. Protein-losing enteropathy could represent both an etiologic factor for hypovitaminosis D, and an obstacle in treating it in IBD patients. There are currently no guidelines for the treatment of hypovitaminosis D in adults or children with IBD. Moreover we have obtained evidence that optimal vitamin D stores (25OHD ≥32 ng/mL) may not be maintained throughout the year in patients with IBD following current RDA recommendations. On the other hand, the prevalence of low bone mineral density is high among young patients with IBD, during a period in their lives when they should experience the most rapid acquisition of bone mass. Optimization of vitamin D status and its impact on the bone health of children with IBD has not been studied. In addition, vitamin D may play an important role in the regulation of the immune system as supported by animal models of colitis and in vitro human studies.
Prospective studies of the effect of vitamin D supplementation on disease outcomes have not been undertaken in children with IBD to date. We aim to perform a) a randomized controlled trial to compare the efficacy of 3 regimens in treating vitamin D insufficiency in pediatric patients with IBD over a period of 6 weeks. We will also evaluate the effects of each regimen on markers of bone resorption, bone formation and parathyroid hormone levels, and the relationship between the magnitude of gastrointestinal protein loss, as reflected by clearance of fecal alpha -1-antitrypsin, and the efficacy of the treatment. b) We also aim to perform a randomized controlled trial to compare the efficacy of 2 regimens of different doses of oral vitamin D2 in maintaining optimal vitamin D stores in pediatric patients with IBD over a period of 2 years. We intend to study the effect of each regimen on a) bone mass acquisition (measured via DXA and pQCT) and bone strength (measured via pQCT), b) bone formation and resorption markers and parathyroid hormone, and c) disease outcomes and disease severity over the same period of time.
Eligibility| Ages Eligible for Study: | 5 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Helen Pappa, MD, MPH | 617-355-2962 | helen.pappa@childrens.harvard.edu |
| Contact: Tracee Saslowsky, MSN | 617-355-4204 | tracee.saslowsky@childrens.harvard.edu |
| United States, Massachusetts | |
| Children's Hospital, Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Helen Pappa, MD | |
| Sub-Investigator: Richard J. Grand, MD | |
| Sub-Investigator: Catherine Gordon, MD | |
| Principal Investigator: | Helen Pappa, MD, MPH | Children's Hospital Boston |
More Information
| Responsible Party: | Children's Hospital, Boston ( Helen Pappa, MD, MPH ) |
| Study ID Numbers: | 1K23DK076979-01A1 |
| Study First Received: | February 11, 2008 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00621257 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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IBD Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Vitamin D |
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Cholecalciferol Crohn's Disease Ileitis Gastrointestinal Diseases Enteritis Ulcer Colonic Diseases Ergocalciferols Inflammatory Bowel Diseases Bone Density Conservation Agents Trace Elements |
Colitis, Ulcerative Intestinal Diseases Ileal Diseases Vitamin D Digestive System Diseases Vitamins Crohn Disease Micronutrients Gastroenteritis Colitis |
|
Cholecalciferol Ileitis Gastrointestinal Diseases Growth Substances Enteritis Ulcer Physiological Effects of Drugs Colonic Diseases Ergocalciferols Inflammatory Bowel Diseases Bone Density Conservation Agents Colitis, Ulcerative |
Intestinal Diseases Ileal Diseases Pharmacologic Actions Vitamin D Pathologic Processes Digestive System Diseases Vitamins Crohn Disease Micronutrients Gastroenteritis Colitis |
