Thiamin Against Robust IBD Fatigue

Phase 4

Completed

• Conditions: Fatigue
• Interventions: Drug: Thiamine; Other: Placebo

• Registration Number: NCT03634735
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-16
• Study Start: 2018-11-27
• Primary Completion: 2020-04-21
• Status Verified: 2020-10
• Study Completion: 2020-10-27
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Inflammatory Bowel Disease
• Disease in remission
• Chronic fatigue

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Exclusion Criteria

• Co-morbidity that can explain fatigue
• Pregnancy
• Non-compliance to the study procedures
• Possible surgery in the study period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Thiamin	Thiamine	Oral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each.
Placebo	Placebo	Placebo: same number of tablets as in the active comparator arm, in 4 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Central Region, Denmark