Trial Outcomes & Findings for Vitamin D Supplementation in Crohn's Patients (NCT NCT00742781)

NCT ID: NCT00742781

Last Updated: 2013-07-26

Results Overview

Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 21 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2013-07-26

Participant Flow

Patients were recruited form the Pennsylvania State University University Park area and Hershey College of Medicine. The University General Clinical Research Centers on the two campuses were utilized. Recruitment was from 5/2009 to 7/2011.

The study was an open label feasibility study that used patients as their own controls. All patients were accepted into the study as long as they met the eligibility requirements.

Participant milestones

Measure	Vitamin D Supplementation
Overall Study STARTED	21
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Vitamin D Supplementation
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Vitamin D Supplementation in Crohn's Patients

Baseline characteristics by cohort

Measure	Vitamin D Supplementation n=21 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	38 years STANDARD_DEVIATION 17 • n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Region of Enrollment United States	21 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe.

Outcome measures

Measure	Baseline n=21 Participants	Vitamin D Supplemented n=18 Participants
Crohn's Disease Activity Index	230 units on a scale Standard Error 74	112 units on a scale Standard Error 81

PRIMARY outcome

Timeframe: 6 months

25(OH)D3 levels before and after vitamin D supplementation.

Outcome measures

Measure	Baseline n=21 Participants	Vitamin D Supplemented n=18 Participants
25(OH)D3 Serum Levels	16 ng/ml 25(OH)D3 Standard Error 10	45 ng/ml 25(OH)D3 Standard Error 19

SECONDARY outcome

Timeframe: 6 months

Population: Activity records for 14 participants were recorded at baseline and after vitamin D supplementation.

International Physical Activity Questionnaire. Minutes/week for 30 min/day, 5days (MET) are calculated for different activity intensities. Total range of scores 0-600 MET low activity, 600-1200 Moderate activity, Over 1200-3000 High activity.

Outcome measures

Measure	Baseline n=14 Participants	Vitamin D Supplemented n=14 Participants
Health Improvement	5778 units on a scale Standard Error 969	6714 units on a scale Standard Error 1327

Adverse Events

Vitamin D Supplemented

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Margherita Cantorna

Pennsylvania State University

Phone: 814-863-2819

Email: mxc69@psu.edu

Results disclosure agreements

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