Trial Outcomes & Findings for Trial of High Dose Vitamin D in Patient's With Crohn's Disease (NCT NCT02208310)

NCT ID: NCT02208310

Last Updated: 2017-10-06

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: Day 180
• Results posted on: 2017-10-06

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	6	5
Overall Study Day 180	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Low Dose Vitamin D n=6 Participants 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	High Dose Vitamin D n=5 Participants 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	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.2 years STANDARD_DEVIATION 14.2 • n=5 Participants	35.2 years STANDARD_DEVIATION 9.0 • n=7 Participants	34.6 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 180

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.

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions	—	0 participants

PRIMARY outcome

Timeframe: Day 180

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.

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Hypercalcemia	—	0 Participants

PRIMARY outcome

Timeframe: Day 180

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.

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Incidence of Nephrolithiasis	—	0 Participants

SECONDARY outcome

Timeframe: Day 180

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.

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Crohn's Related Hospitalizations	—	0 CD-related hospitalization occurred

SECONDARY outcome

Timeframe: Day 180

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

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Steroid Prescription Given (Dichotomous 0/1)	—	0 Steroid prescription occurred

SECONDARY outcome

Timeframe: Day 180

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

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)	—	0 CD-related surgery occurred

SECONDARY outcome

Timeframe: Day 180

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.

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Change in Modified Harvey-Bradshaw Index (HBI Without Examination)	—	1 units on a scale (0-16)

SECONDARY outcome

Timeframe: Day 180

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.

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Change in C-reactive Protein	—	0 mg/dL

SECONDARY outcome

Timeframe: 1 year

Population: Results were not collected on any subjects

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 180

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.

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Percent With Escalation of Therapy	—	0 Participants

SECONDARY outcome

Timeframe: Day 180

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.

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Quality of Life Measure Changes	—	-7 units on a scale

SECONDARY outcome

Timeframe: Day 180

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.

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Change in Fatigue Measurements	—	-3 units on a scale

SECONDARY outcome

Timeframe: Day 180

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

Outcome measures

Measure	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	High Dose Vitamin D n=1 Participants 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
Participants With at Least One Crohn's Related Emergency Department (ED) Visit	—	0 participants

Adverse Events

Low Dose Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Dose Vitamin D

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low Dose Vitamin D n=6 participants at risk 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	High Dose Vitamin D n=5 participants at risk 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
Renal and urinary disorders Urinary Tract Infection	0.00% 0/6 • 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	20.0% 1/5 • Number of events 1 • 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

Additional Information

Peter Higgins

University of Michigan

Phone: 7346472964

Email: phiggins@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place