Fatigue
Conditions
Keywords
Inflammatory Bowel Disease, Fatigue, Thiamine, Vitamin B1
Brief summary
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.
Detailed description
Patients with Inflammatory Bowel Disease (IBD), disease in remission and chronic fatigue will receive high dose oral Thiamine treatment for 4 weeks in a RCT, cross-over study. After the high dose treatment period, participants will be randomized to 3 months treatment with Thiamine 300mg/day or placebo.
Interventions
DRUGThiamine
Vitamine B1
OTHERPlacebo
Placebo tablets
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double blinded
Intervention model description
RCT and crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | After 4 weeks active treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease specific Health-Related Quality of Life | Week 4, 8, 12, 24, and 52 | 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). |
| Fatigue | Week 8, 12, 24, and 52 | 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. |
| Health-Related Quality of Life | Week 4, 8, 12, 24, and 52 | Changes in Health-Related Quality of Life, measured by the generic EQ-5D Tool (mainly the VAS-scale (0-100, where100 is best). |
Countries
Denmark
Outcome results
None listed