Thiamin Against Robust IBD Fatigue

Fatigue Clinical Trial

Official title:

Thiamin Against Robust IBD Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634735
• Other study ID #: TARIF
• Status: Completed
• Phase: Phase 4
• Start date: November 27, 2018
• Est. completion date: October 27, 2020

Study information

• Verified date: October 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fatigue

Intervention

Drug:
• Thiamine
Vitamine B1

Other:
• Placebo
Placebo tablets

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Central Region

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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