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Thiamin Against Robust IBD Fatigue

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT03634735
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
23
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
RCT and crossoverRCT 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 :
Nov 27, 2018
Actual Primary Completion Date :
Apr 21, 2020
Actual Study Completion Date :
Oct 27, 2020

Arms and Interventions

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 Names:
  • Vitamine B1

    		•
    Placebo Comparator: Placebo

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

    Other: Placebo
    Placebo tablets

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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).

    3. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital Aarhus Central Region Denmark 8000

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT03634735
    Other Study ID Numbers:
    • TARIF
    First Posted:
    Aug 16, 2018
    Last Update Posted:
    Oct 29, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Fatigue
    Thiamine

    Study Results

    No Results Posted as of Oct 29, 2020