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

NCT02208310 | Terminated Phase 4 Results

• 1 other identifier: CCFA-329225
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 4

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.

Conditions

Crohn's Disease; Vitamin D Deficiency

Keywords

Crohn's disease; Vitamin D deficiency

Outcome Measures

Primary Outcomes (3)

• Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions

  Composite endpoint of (any of) Crohn's disease(CD)-related hospitalizations, CD-related surgeries, CD-related ER visits, or steroid prescriptions. Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.

  Day 180

• Hypercalcemia

  Hypercalcemia is presented as number of participants with Calcium \>10.8 mg/dl Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.

  Day 180

• Incidence of Nephrolithiasis

  Incidence of nephrolithiasis associated with hypercalcemia (\>10.8mg/dl) documented by imaging Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.

  Day 180

Secondary Outcomes (10)

• Crohn's Related Hospitalizations

  Day 180

• Steroid Prescription Given (Dichotomous 0/1)

  Day 180

• Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)

  Day 180

• Change in Modified Harvey-Bradshaw Index (HBI Without Examination)

  Day 180

• Change in C-reactive Protein

  Day 180

Study Arms (2)

Low Dose Vitamin D

ACTIVE COMPARATOR

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.

Drug: Cholecalciferol 400 IU

High Dose Vitamin D

EXPERIMENTAL

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.

Drug: Cholecalciferol 10,000 IU

Interventions

Cholecalciferol 10,000 IU DRUG

Cholecalciferol 10,000 IU po daily

Also known as: High Dose Vitamin D

High Dose Vitamin D

Cholecalciferol 400 IU DRUG

Cholecalciferol 400 IU po daily

Also known as: Low dose vitamin D

Low Dose Vitamin D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Michigan: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (4)

Indiana University

Indianapolis, Indiana, 46001, United States

Location

University of Iowa

Iowa City, Iowa, 55240, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (4)

• 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.

  PMID: 20491740 BACKGROUND

• 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.

  PMID: 22241842 BACKGROUND

• 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.

  PMID: 11053501 BACKGROUND

• 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.

  PMID: 22155183 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Vitamin D Deficiency

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

Very few patients with inactive disease had low vitamin D levels, so most patients screened were ineligible. This made recruitment very slow, and the project was terminated.Suggests low vitamin D could be a marker of activity, rather than a cause

Results Point of Contact

• Title: Peter Higgins
• Organization: University of Michigan

phiggins@umich.edu

7346472964

Study Officials

• Peter D. Higgins, MD, PhD, MSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Shail M Govani, M.D., M.Sc.

  University of Michigan

  STUDY DIRECTOR

• Hans Herfarth, MD, PhD

  University of North Carolina

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 5, 2014
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 6, 2017
• Results First Posted: October 6, 2017

Record last verified: 2017-08

Locations

US (4)