Clinical trial NCT02208310: Trial of High Dose Vitamin D in Patient's With Crohn's Disease
Official title: A Randomized Controlled Trial of High-Dose Vitamin D in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Crohn's Disease
Vitamin D Deficiency
Keywords: Crohn's disease
Vitamin D deficiency
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Foundation
First posted: 2014-08-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions
timeFrame: Day 180
measure: Hypercalcemia
timeFrame: Day 180
measure: Incidence of Nephrolithiasis
timeFrame: Day 180
Secondary outcomes:
measure: Crohn's Related Hospitalizations
timeFrame: Day 180
measure: Steroid Prescription Given (Dichotomous 0/1)
timeFrame: Day 180
measure: Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)
timeFrame: Day 180
measure: Change in Modified Harvey-Bradshaw Index (HBI Without Examination)
timeFrame: Day 180
measure: Change in C-reactive Protein
timeFrame: Day 180
measure: Changes in Fecal Calprotectin
timeFrame: 1 year
measure: Percent With Escalation of Therapy
timeFrame: Day 180
measure: Quality of Life Measure Changes
timeFrame: Day 180
measure: Change in Fatigue Measurements
timeFrame: Day 180
measure: Participants With at Least One Crohn's Related Emergency Department (ED) Visit
timeFrame: Day 180
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of Michigan
name: Peter D. Higgins, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Shail M Govani, M.D., M.Sc.
role: STUDY_DIRECTOR
affiliation: University of North Carolina
name: Hans Herfarth, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Jorgensen SP, Agnholt J, Glerup H, Lyhne S, Villadsen GE, Hvas CL, Bartels LE, Kelsen J, Christensen LA, Dahlerup JF. Clinical trial: vitamin D3 treatment in Crohn's disease - a randomized double-blind placebo-controlled study. Aliment Pharmacol Ther. 2010 Aug;32(3):377-83. doi: 10.1111/j.1365-2036.2010.04355.x. Epub 2010 May 11.
citation: Khalili H, Huang ES, Ananthakrishnan AN, Higuchi L, Richter JM, Fuchs CS, Chan AT. Geographical variation and incidence of inflammatory bowel disease among US women. Gut. 2012 Dec;61(12):1686-92. doi: 10.1136/gutjnl-2011-301574. Epub 2012 Jan 11.
citation: Cantorna MT, Munsick C, Bemiss C, Mahon BD. 1,25-Dihydroxycholecalciferol prevents and ameliorates symptoms of experimental murine inflammatory bowel disease. J Nutr. 2000 Nov;130(11):2648-52. doi: 10.1093/jn/130.11.2648.
citation: Ananthakrishnan AN, Khalili H, Higuchi LM, Bao Y, Korzenik JR, Giovannucci EL, Richter JM, Fuchs CS, Chan AT. Higher predicted vitamin D status is associated with reduced risk of Crohn's disease. Gastroenterology. 2012 Mar;142(3):482-9. doi: 10.1053/j.gastro.2011.11.040. Epub 2011 Dec 9.