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Thiamin Against Robust IBD Fatigue

Primary Purpose

Fatigue

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Thiamine
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Inflammatory Bowel Disease, Fatigue, Thiamine, Vitamin B1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Thiamin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fatigue
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

Fatigue
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
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
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).

Full Information

First Posted
June 11, 2018
Last Updated
October 28, 2020
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT03634735
Brief Title
Thiamin Against Robust IBD Fatigue
Official Title
Thiamin Against Robust IBD Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
April 21, 2020 (Actual)
Study Completion Date
October 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Inflammatory Bowel Disease, Fatigue, Thiamine, Vitamin B1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
RCT and crossover
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double blinded
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thiamin
Arm Type
Active Comparator
Arm Description
Oral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: same number of tablets as in the active comparator arm, in 4 weeks
Intervention Type
Drug
Intervention Name(s)
Thiamine
Other Intervention Name(s)
Vitamine B1
Intervention Description
Vitamine B1
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets
Primary Outcome Measure Information:
Title
Fatigue
Description
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.
Time Frame
After 4 weeks active treatment
Secondary Outcome Measure Information:
Title
Fatigue
Description
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.
Time Frame
Week 8, 12, 24, and 52
Title
Health-Related Quality of Life
Description
Changes in Health-Related Quality of Life, measured by the generic EQ-5D Tool (mainly the VAS-scale (0-100, where100 is best).
Time Frame
Week 4, 8, 12, 24, and 52
Title
Disease specific Health-Related Quality of Life
Description
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).
Time Frame
Week 4, 8, 12, 24, and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Central Region
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34592862
Citation
Bager P, Hvas CL, Rud CL, Dahlerup JF. Long-term maintenance treatment with 300 mg thiamine for fatigue in patients with inflammatory bowel disease: results from an open-label extension of the TARIF study. Scand J Gastroenterol. 2022 Jan;57(1):37-43. doi: 10.1080/00365521.2021.1983640. Epub 2021 Sep 30.
Results Reference
derived
PubMed Identifier
33210299
Citation
Bager P, Hvas CL, Rud CL, Dahlerup JF. Randomised clinical trial: high-dose oral thiamine versus placebo for chronic fatigue in patients with quiescent inflammatory bowel disease. Aliment Pharmacol Ther. 2021 Jan;53(1):79-86. doi: 10.1111/apt.16166. Epub 2020 Nov 18.
Results Reference
derived

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Thiamin Against Robust IBD Fatigue

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