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OpenTrials
Completed

NCT Number: NCT03634735

Thiamin Against Robust IBD Fatigue

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.

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Key information

Conditions

Fatigue Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital

Aarhus, Central Region, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thiamine

Drug

Vitamine B1

Other names: Vitamine B1

Placebo

Other

Placebo tablets

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 16, 2018
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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