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Crohn's DiseasePhase 4RODIN-CDNCT02208310

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

A Phase 4 study testing Cholecalciferol 10,000 IU and Cholecalciferol 400 IU in people with Crohn's Disease and Vitamin D Deficiency, run by University of Michigan at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease, Vitamin D Deficiency
What is being tested?
Cholecalciferol 10,000 IU and Cholecalciferol 400 IU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
4 sitesUnited States
Study dates
Apr 2015to Apr 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 17Show fewer
  • 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 locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Indiana University

    Indianapolis, Indiana, 46001

  • University of Iowa

    Iowa City, Iowa, 55240

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of High-Dose Vitamin D in Crohn's Disease

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.

Read the 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.

Being tested
Cholecalciferol 10,000 IU, Cholecalciferol 400 IU
Keywords
Crohn's disease, Vitamin D deficiency
Medical subject headings
Crohn Disease, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cholecalciferol 10,000 IUDrug

    Also called High Dose Vitamin D

    Cholecalciferol 10,000 IU po daily

  • Cholecalciferol 400 IUDrug

    Also called Low dose vitamin D

    Cholecalciferol 400 IU po daily

Study groups in NCT02208310
Study groupRoleWhat they receive
Low Dose Vitamin DActive comparatorPatients 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.
Receives: Drug: Cholecalciferol 400 IU
High Dose Vitamin DExperimentalPatients 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.
Receives: Drug: Cholecalciferol 10,000 IU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 180

  2. 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.

    Measured: Day 180

  3. 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.

    Measured: Day 180

Secondary outcomes (10)

  1. Crohn's Related Hospitalizations

    Dichotomous (0/1) endpoint for each subject, depending on whether a CD-related hospitalization occurred. Relatedness to Crohn's disease as judged by the DSMB. 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.

    Measured: Day 180

  2. Steroid Prescription Given (Dichotomous 0/1)

    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. No steroid prescriptions occurred

    Measured: Day 180

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

    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. No CD-related surgeries occurred in the 1 subject

    Measured: Day 180

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

    modified Harvey-Bradshaw is a disease assessment scale. 0 is the lowest score and would be considered remission. Scale ranges to over 16 (upper limit is defined by the number of bowel movements in the prior day) with numbers over 16 being severe disease. A positive change (such as that indicated below) therefore references slightly worsening disease while a negative change references improving disease.

    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. 1 subject had an increase of 1 unit on the modified HBI.

    Measured: Day 180

  5. Change in C-reactive Protein

    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. The delta between first (baseline) and last CRP (Day 180) is reported here.

    Measured: Day 180

  6. Changes in Fecal Calprotectin

    Originally planned to collect at Day 180 and Day 360. Results were not collected on any subjects, as the one participant did not provide a stool sample.

    Measured: 1 year

  7. Percent With Escalation of Therapy

    Patients who had to have a change in therapy 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.

    Measured: Day 180

  8. Quality of Life Measure Changes

    change in quality of life measures based on Inflammatory bowel disease questionnaire (IBD-Q).

    Scale from 0 to 224 with 0 being the poorest quality of life and 224 being the highest quality of life. A positive change indicates improvement while a negative change indicates worsening.

    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.

    Measured: Day 180

  9. Change in Fatigue Measurements

    Change in FACIT-F scale over the year. Scale is 0-160 with 0 being no fatigue and 160 being extreme fatigue. A positive change indicates worsening in symptoms and a negative change indicates an improvement.

    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.

    Measured: Day 180

  10. Participants With at Least One Crohn's Related Emergency Department (ED) Visit

    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. No CD-related ED visits occurred in the 1 subject

    Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionApr 2016
  4. Study completionApr 2016

Why it stopped: Unable to enroll at rate anticipated, insufft low vitamin D in clin rem @ 5 sites

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02208310
Sponsor's protocol ID
CCFA-329225
Acronym
RODIN-CD
Status last verified
Aug 2017
First submitted
1 Aug 2014
Last updated
6 Oct 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 20491740

  • 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.

    PubMed 22241842

  • 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.

    PubMed 11053501

  • 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.

    PubMed 22155183

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cholecalciferol 10,000 IU and Cholecalciferol 400 IU in people with Crohn's Disease and Vitamin D Deficiency, run by University of Michigan at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions (time frame: Day 180). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02208310, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.

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