High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade



Status:Recruiting
Conditions:Colitis, Gastrointestinal, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:7 - 25
Updated:5/30/2018
Start Date:August 1, 2017
End Date:December 30, 2018
Contact:Paul A Rufo
Email:paul.rufo@childrens.harvard.edu
Phone:6174692620

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Trial Summary
Trial Overview
Inclusion Criteria
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.

Inclusion Criteria:

- Existing diagnosis of IBD

- Age 0-25 years

- Measured serum level of 25-OH Vitamin D of 15-29 ng/ml in the last 8 weeks and no
changes in Vitamin D supplementation in the interim

Exclusion Criteria:

- Pregnant Women

- History of underlying kidney disease

- History of granulomatous disease

- Inability to take oral Vitamin D

- History of hypercalcemia or hypercalciuria

- Currently taking an anti-epileptic medication

- History of pre-existing liver disease (excluding primary sclerosing cholangitis,
non-alcoholic fatty liver disease, or steatohepatitis)
We found this trial at
1
site
Boston Children's Hospital
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Paul A. Rufo, MD, MMSc
Phone: 617-469-2620
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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