Fatigue Clinical Trial
Official title:
Thiamin Against Robust IBD Fatigue
Verified date | October 2020 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with Inflammatory Bowel Disease (IBD), disease in remission and chronic fatigue will receive oral Thiamine treatment for 4 weeks in a RCT, cross-over study.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 27, 2020 |
Est. primary completion date | April 21, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Inflammatory Bowel Disease - Disease in remission - Chronic fatigue Exclusion Criteria: - Co-morbidity that can explain fatigue - Pregnancy - Non-compliance to the study procedures - Possible surgery in the study period |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | Central Region |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue | Change in levels of fatigue measured by the Inflammatory Bowel Disease Fatigue Scale (IBD-F). Section I of the scale measures the severity of fatigue on a scale from 0-20, where 20 is maximum fatigue. A change in IBD-F score of 3 points or more is regarded as a clinical relevant change. | After 4 weeks active treatment | |
Secondary | Fatigue | Change in levels of fatigue measured by the Inflammatory Bowel Disease Fatigue Scale (IBD-F). Section I of the scale measures the severity of fatigue on a scale from 0-20, where 20 is maximum fatigue. A change in IBD-F score of 3 points or more is regarded as a clinical relevant change. | Week 8, 12, 24, and 52 | |
Secondary | Health-Related Quality of Life | Changes in Health-Related Quality of Life, measured by the generic EQ-5D Tool (mainly the VAS-scale (0-100, where100 is best). | Week 4, 8, 12, 24, and 52 | |
Secondary | Disease specific Health-Related Quality of Life | Changes in Health-Related Quality of Life, measured by the disease specific Short Health Scale (SHS). SHS comprises 4 questions regarding disease related quality of life on VAS-scales (0-10, where 10 is worst). | Week 4, 8, 12, 24, and 52 |
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