- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00621257
Vitamin D Levels in Children With IBD
Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital, Boston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of inflammatory bowel disease
- serum 25OHD level ≤ 20 ng/mL (Treatment Trial)
- serum 25OHD level > 20 ng/mL (Maintenance Trial)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment A
2,000 IU/day of ergocalciferol orally for 6 weeks (control arm)
|
8000 units/ml
Other Names:
|
Experimental: Treatment B
2,000 IU/day of cholecalciferol orally for 6 weeks
|
400 units per drop
Other Names:
|
Experimental: Treatment C
50,000 IU of ergocalciferol once a week orally for 6 weeks
|
8000 units/ml
Other Names:
|
Active Comparator: Maintenance A
400 IU/day of ergocalciferol orally over 2 years (control arm)
|
8000 units/ml
Other Names:
|
Experimental: Maintenance B
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
|
8000 units/ml
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease
Time Frame: 12 months
|
Percentage of pediatric patients with inflammatory bowel disease who maintained their serum 25OHD level at or above 32 ng/mL at all study visits over the duration of the maintenance study 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.
Concentration at or above 32 ng/mL has been identified as optimal vitamin D level for bone health by majority of experts.
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Helen Pappa, MD, MPH, Boston Children's Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Ulcer
- Inflammatory Bowel Diseases
- Crohn Disease
- Intestinal Diseases
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- 1K23DK076979-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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