Trial of High Dose Vitamin D in Patient's With Crohn's Disease (RODIN-CD)

University of Michigan

Status and phase: Terminated; Phase 4

Conditions: Vitamin D Deficiency; Crohn's Disease

Treatments: Drug: Cholecalciferol 400 IU; Drug: Cholecalciferol 10,000 IU

Study type: Interventional

Funder types: Other

Identifiers

NCT02208310

CCFA-329225

Details and patient eligibility

About

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.

Full description

Subjects are randomized to low or high dose vitamin D, and outcomes including steroid prescriptions, CD-related hospitalizations, CD-related surgeries, and the modified Harvey-Bradshaw Index are measured.

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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11 participants in 2 patient groups

Low Dose Vitamin D

Active Comparator group

Description:

Patients will be given 400 IU cholecalciferol once daily for 30 days. \<-THIS IS THE Active Comparator Intervention. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.

Treatment:

Drug: Cholecalciferol 400 IU

High Dose Vitamin D

Experimental group

Description:

Patients will be given cholecalciferol 10,000 IU daily for 30 days. \<-THIS IS THE INTERVENTION. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if \<50 ng/ml, a 30 day course will be administered.

Treatment:

Drug: Cholecalciferol 10,000 IU