Not provided
Not provided
Not provided
Not provided
Unable to enroll at rate anticipated, insufft low vitamin D in clin rem @ 5 sites
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Crohn's and Colitis Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol 10,000 IU | Drug | Cholecalciferol 10,000 IU po daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 180 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46001 | United States | ||
| University of Iowa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20491740 | Background | 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. | |
| 22241842 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Vitamin D | Patients will be given 400 IU cholecalciferol once daily for 30 days. 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. Cholecalciferol 400 IU |
| FG001 | High Dose Vitamin D | Patients will be given cholecalciferol 10,000 IU daily for 30 days. 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. Cholecalciferol 10,000 IU |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Vitamin D | Patients will be given 400 IU cholecalciferol once daily for 30 days. 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. Cholecalciferol 400 IU |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | Day 180 |
|
AEs are reported for as long as participants remained in the study. All but one had left short of 6 months; one continued through the 6 month milestone.
Not different
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose Vitamin D | Patients will be given 400 IU cholecalciferol once daily for 30 days. 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. Cholecalciferol 400 IU |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | SNOMED CT | Non-systematic Assessment | Urinary Tract Infection |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Higgins | University of Michigan | 7346472964 | phiggins@umich.edu |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cholecalciferol 400 IU | Drug | Cholecalciferol 400 IU po daily |
|
|
| 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 |
| Day 180 |
| 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 | Day 180 |
| 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. | Day 180 |
| 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. | Day 180 |
| 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. | 1 year |
| 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. | Day 180 |
| 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. | Day 180 |
| 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. | Day 180 |
| 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 | Day 180 |
| Iowa City |
| Iowa |
| 55240 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| 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. |
| 11053501 | 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. |
| 22155183 | 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. |
| High Dose Vitamin D |
Patients will be given cholecalciferol 10,000 IU daily for 30 days. 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. Cholecalciferol 10,000 IU |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| High Dose Vitamin D |
Patients will be given cholecalciferol 10,000 IU daily for 30 days. 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. Cholecalciferol 10,000 IU |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Day 180 |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Day 180 |
|
|
|
| Secondary | 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. | Posted | Number | CD-related hospitalization occurred | Day 180 |
|
|
|
| Secondary | 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 | Posted | Number | Steroid prescription occurred | Day 180 |
|
|
|
| Secondary | 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 | Posted | Number | CD-related surgery occurred | Day 180 |
|
|
|
| Secondary | 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. | Posted | Number | units on a scale (0-16) | Day 180 |
|
|
|
| Secondary | 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. | Posted | Number | mg/dL | Day 180 |
|
|
|
| Secondary | 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. | Results were not collected on any subjects | Posted | 1 year |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Day 180 |
|
|
|
| Secondary | 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. | Posted | Number | units on a scale | Day 180 |
|
|
|
| Secondary | 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. | Posted | Number | units on a scale | Day 180 |
|
|
|
| Secondary | 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 | Posted | Number | participants | Day 180 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | High Dose Vitamin D | Patients will be given cholecalciferol 10,000 IU daily for 30 days. 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. Cholecalciferol 10,000 IU | 0 | 5 | 0 | 5 | 1 | 5 |
|
Not provided
Not provided
| D007410 | Intestinal Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |