FatiguePhase 4NCT03634735
Thiamin Against Robust IBD Fatigue
A Phase 4 study testing Thiamine in people with Fatigue, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue
- What is being tested?
- Thiamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Nov 2018to 27 Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inflammatory Bowel Disease
- Disease in remission
- Chronic fatigue
Who cannot join
- Co-morbidity that can explain fatigue
- Pregnancy
- Non-compliance to the study procedures
- Possible surgery in the study period
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fatigue
- Being tested
- Thiamine, Placebo
- Keywords
- Inflammatory Bowel Disease, Fatigue, Thiamine, Vitamin B1
- Medical subject headings
- Fatigue, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiamineDrug
Also called Vitamine B1
Vitamine B1
PlaceboOther
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Thiamin | Active comparator | Oral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each. Receives: Drug: Thiamine |
| Placebo | Placebo comparator | Placebo: same number of tablets as in the active comparator arm, in 4 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 4 weeks active treatment
Secondary outcomes (3)
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.
Measured: Week 8, 12, 24, and 52
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).
Measured: Week 4, 8, 12, 24, and 52
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).
Measured: Week 4, 8, 12, 24, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start27 Nov 2018
- Primary completion21 Apr 2020
- Study completion27 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- RCT and crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634735
- Sponsor's protocol ID
- TARIF
- Status last verified
- Oct 2020
- First submitted
- 11 Jun 2018
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bager P, Hvas CL, Hansen MM, Ueland P, Dahlerup JF. B-vitamins, related vitamers, and metabolites in patients with quiescent inflammatory bowel disease and chronic fatigue treated with high dose oral thiamine. Mol Med. 2023 Oct 25;29(1):143. doi: 10.1186/s10020-023-00741-3.
PubMed 37880581Bager 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.
PubMed 34592862Bager 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.
PubMed 33210299
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thiamin Against Robust IBD Fatigue
- ClinicalTrials.gov ID
- NCT03634735
- Acronym / sponsor ID
- TARIF
- Conditions
- Fatigue
- Keywords
- Inflammatory Bowel Disease, Fatigue, Thiamine, Vitamin B1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 27 Oct 2020 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- RCT and crossover
| Arm | Type | Receives |
|---|---|---|
| Thiamin | Active comparator | Drug: ThiamineOral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo: same number of tablets as in the active comparator arm, in 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inflammatory Bowel Disease
- Disease in remission
- Chronic fatigue
Key exclusion criteria (4 listed)
- Co-morbidity that can explain fatigue
- Pregnancy
- Non-compliance to the study procedures
- Possible surgery in the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiamineAlso: Vitamine B1Vitamine B1 | Drug | Thiamin |
| PlaceboPlacebo tablets | Other | Placebo |
Primary outcome
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.
3 secondary outcomes
Fatigue
Time frame: Week 8, 12, 24, and 52
Health-Related Quality of Life
Time frame: Week 4, 8, 12, 24, and 52
Disease specific Health-Related Quality of Life
Time frame: Week 4, 8, 12, 24, and 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Derived from this study: PubMed 37880581Bager P, Hvas CL, Hansen MM, Ueland P, Dahlerup JF. B-vitamins, related vitamers, and metabolites in patients with quiescent inflammatory bowel disease and chronic fatigue treated with high dose oral thiamine. Mol Med. 2023 Oct 25;29(1):143. doi: 10.1186/s10020-023-00741-3.
- Derived from this study: PubMed 34592862Bager 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.
- Derived from this study: PubMed 33210299Bager 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thiamine in people with Fatigue, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: After 4 weeks active treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03634735, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.