Thiamin Against Robust IBD Fatigue

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Fatigue

Treatments: Other: Placebo; Drug: Thiamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03634735

TARIF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Thiamin

Active Comparator group

Description:

Oral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each.

Treatment:

Drug: Thiamine

Placebo

Placebo Comparator group

Description:

Placebo: same number of tablets as in the active comparator arm, in 4 weeks

Treatment:

Other: Placebo