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Thiamin Against Robust IBD Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03634735
Recruitment Status : Active, not recruiting
First Posted : August 16, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fatigue Drug: Thiamine Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: RCT and crossover
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double blinded
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
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.
Drug: Thiamine
Vitamine B1
Other Name: Vitamine B1

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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Denmark
Aarhus University Hospital
Aarhus, Central Region, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03634735    
Other Study ID Numbers: TARIF
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Inflammatory Bowel Disease
Fatigue
Thiamine
Vitamin B1
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms
Thiamine
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex