Trial of High Dose Vitamin D in Patient's With Crohn's Disease

Stopped early · Phase 4

Conditions studied: Crohn's Disease, Vitamin D Deficiency

In brief

Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is a major source of vitamin D. There is some research to suggest that patient's with higher vitamin D levels are less likely to undergo surgeries and have better control of their disease. We intend to study the effects of high dose vitamin D supplementation in patients with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses will have less hospitalizations, surgeries, steroid use.

Key facts

Study ID

NCT02208310

Run by

University of Michigan

People needed

11

Starts

2015-04-01

Expected to finish

2016-04-01

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of CD
• Age >= 18 and <75
• Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D < 30ng/ml)

You may not qualify if…

• Corticosteroid use in the last 4 weeks
• CD-related surgery in the last 6 months
• CD-related hospitalization in the last 4 weeks
• Pregnancy, intended pregnancy during the study period or nursing
• Serum calcium >10.2 mg/dL
• History of primary sclerosing cholangitis
• History of undergoing an ileal pouch-anal anastomosis
• Current active perianal disease
• History of nephrolithiasis in the past 2 years
• Anticipated change in therapy in the next 30 days (steroids, biologic initiation)
• modified Harvey-Bradshaw Index of 10 or more
• History of decreased renal function (glomerular filtration rate <30ml/min based on MDRD) or polycystic kidney disease
• History of sarcoidosis
• History of hyperparathyroidism
• Any other chronic condition that may preclude high doses of Vitamin D such as lymphoma
• Concurrent use of hydrochlorothiazide, phenytoin, phenobarbital, carbamazepine or primidone
• Osteoporosis

Where it is running

• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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