Thiamin Against Robust IBD Fatigue
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|ClinicalTrials.gov Identifier: NCT03634735|
Recruitment Status : Active, not recruiting
First Posted : August 16, 2018
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fatigue||Drug: Thiamine Other: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||RCT and crossover|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Double blinded|
|Official Title:||Thiamin Against Robust IBD Fatigue|
|Actual Study Start Date :||November 27, 2018|
|Actual Primary Completion Date :||April 21, 2020|
|Estimated Study Completion Date :||November 2020|
Active Comparator: Thiamin
Oral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each.
Other Name: Vitamine B1
Placebo Comparator: Placebo
Placebo: same number of tablets as in the active comparator arm, in 4 weeks
- Fatigue [ Time Frame: 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.
- Fatigue [ Time Frame: 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 [ Time Frame: 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).
- Disease specific Health-Related Quality of Life [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634735
|Aarhus University Hospital|
|Aarhus, Central Region, Denmark, 8000|