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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 (cholecalciferol) | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline serum 25-OH vitamin D level at 8 and 12 weeks | Weeks 0, 8 and 12 of study. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Subra Kugathasan, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta, Egleston Children's Hospital | Atlanta | Georgia | 30322 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22924607 | Background | 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. | |
| 21694532 |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D010859 | Pigmentation Disorders |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Emory Children's Center |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Background |
| 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. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |