Inflammatory Bowel Disease
Conditions
Keywords
Crohn's, vitamin D
Brief summary
The purpose of this study is to determine the effect of vitamin D supplementation in Crohn's disease patients. Patients will be evaluated for increases in circulating vitamin D levels and effects on health benefits including improved bone markers, Crohn's disease activity scores, and inflammatory markers.
Detailed description
The incidence of autoimmune diseases like inflammatory bowel disease (IBD) has increased in developed countries over the last 50 years. We propose that decreased outdoor activity and increased pollution and diets that lack adequate vitamin D have combined to create large fluctuations in vitamin D status in developed countries and especially in populations that experience winter. Experimentally we've shown that changes in vitamin D status results in more severe forms of experimental IBD. In addition, active vitamin D (1,25(OH)2D3) completely blocks the development of experimental IBD. The vitamin D hypothesis proposes that vitamin D regulates the development and function of the immune system and that changes in vitamin D status affect the development of the resultant immune response and the development of diseases like IBD. Our hypothesis is that because of low dietary vitamin D intakes and malabsorption of many nutrients, Crohn's patients will have low circulating vitamin D levels that are detrimental for their health. We plan to give Crohn's patients 1000 IU of vitamin D/d and determine whether this dose is well tolerated, induces an increase in circulating vitamin D levels and has any additional health benefits (improved bone markers, Crohn's disease activity scores, inflammatory markers).
Interventions
DIETARY_SUPPLEMENTVitamin D
Oral supplementation daily with up to 5000 IU over 6 months.
Sponsors
Penn State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18-70 years of age with mild to moderate Crohn's disease who are not on active steroid treatment and who do not have ostomies.
Exclusion criteria
* Patients with ulcerative colitis or other bowel conditions which are not Crohn's. * Patients with ostomies. * Those currently using supplemental vitamin D in excess of the amount in one multivitamin per day. * Regular tanning bed users. * Persons who report more than moderate alcohol consumption ( \> 1 drink/day for women \> 2 for men). * Pregnant or lactating women or women planning a pregnancy during the study time frame. * Regular users of medications which may interfere with assessment of study outcomes . * Those who cannot understand written or spoken English . * Individuals under medical psychiatric care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crohn's Disease Activity Index | 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. |
| 25(OH)D3 Serum Levels | 6 months | 25(OH)D3 levels before and after vitamin D supplementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Improvement | 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D Supplementation | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Vitamin D Supplementation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age Continuous | 38 years STANDARD_DEVIATION 17 |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
25(OH)D3 Serum Levels
25(OH)D3 levels before and after vitamin D supplementation.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | 25(OH)D3 Serum Levels | 16 ng/ml 25(OH)D3 | Standard Error 10 |
| Vitamin D Supplemented | 25(OH)D3 Serum Levels | 45 ng/ml 25(OH)D3 | Standard Error 19 |
Primary
Crohn's Disease Activity Index
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Crohn's Disease Activity Index | 230 units on a scale | Standard Error 74 |
| Vitamin D Supplemented | Crohn's Disease Activity Index | 112 units on a scale | Standard Error 81 |
Secondary
Health Improvement
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.
Time frame: 6 months
Population: Activity records for 14 participants were recorded at baseline and after vitamin D supplementation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Health Improvement | 5778 units on a scale | Standard Error 969 |
| Vitamin D Supplemented | Health Improvement | 6714 units on a scale | Standard Error 1327 |