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The goal of this study will be to assess the safety and efficacy of high-dose interval Vitamin D3 therapy in children and young adults with Inflammatory Bowel Disease being treated with serial Remicade infusions.
Study subjects will receiving 50,000 units of Vitamin D3 if they receive Remicade infusions every 4-6 weeks. Study subjects will receiving 100,000 units of Vitamin D3 if they receive Remicade infusions every 6-8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 Treatment | Experimental | Subjects receiving Remicade will be treated with oral Vitamin D3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Oral Vitamin D3 therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability of intervention to maintain 25-OH Vitamin D levels in the 35-80 range | The study will involve measuring serum 25-OH Vitamin D levels after the initiation of open-label therapy. This will be done approximately one month after starting therapy, at the end of the study interval (one year), and as clinically indicated over the course of the year. Serum 25-OH Vitamin D levels are the most robust metric for assessing Vitamin D sufficiency. | Patients will continue to receive oral Vitamin D therapy for one year. We will be assessing the efficacy of oral Vitamin D therapy, in this dosing schema, to result in 25-OH Vitamin D levels during and at the conclusion of this one-year study. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess risk of kidney stones development in patients treated with high-dose interval Vitamin D | Patients will provide a spot urine collection the day prior to their Remicade infusion. A second spot urine collection will be collected on the day of the infusion. Urinary calcium excretion will be assessed. Changes in urinary calcium excretion will be used to identify subjects at risk for the development of renal stones. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35045559 | Derived | Gordon RJ, Wells R, Johansen C, Liu S, Dahlberg SE, Snapper SB, Rufo PA. Efficacy and Safety of High-dose Cholecalciferol in Patients With Inflammatory Bowel Disease Receiving Infliximab. J Pediatr Gastroenterol Nutr. 2022 Apr 1;74(4):476-483. doi: 10.1097/MPG.0000000000003386. Epub 2022 Jan 18. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System 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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| Patients will be monitored for urinary symptoms and complete serial urine assessments as outlined in the protocol. The impact of oral Vitamin D administration on calcium excretion will be evaluated during and at the conclusion of this one-year study. |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |