NCT03634735 is a Phase 4 clinical trial of Thiamine in Fatigue, sponsored by University of Aarhus.

Who is sponsoring NCT03634735?

NCT03634735 is sponsored by University of Aarhus.

What drugs are being tested in NCT03634735?

Interventions in NCT03634735: Thiamine, Placebo.

Is NCT03634735 still recruiting?

NCT03634735 is currently completed. Last updated 29 October 2020.

Last reviewed 2020-10-29 · How we verify

NCT03634735

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Thiamin Against Robust IBD Fatigue

Completed Phase 4 Last updated 29 October 2020

What this trial tests

Phase 4 trial testing Thiamine in Fatigue in 40 participants. Completed in 27 October 2020.

Timeline

27 November 2018

Primary endpoint
21 April 2020

27 October 2020

Quick facts

Lead sponsor	University of Aarhus
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	40
Start date	27 November 2018
Primary completion	21 April 2020
Estimated completion	27 October 2020
Sites	1 location across Denmark

Drugs / interventions tested

Thiamine (THIAMINE) — full drug profile →
Placebo

Conditions studied

Fatigue — all drugs for Fatigue →

Sponsor

University of Aarhus

Who can join

18 and older, any sex, with Fatigue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Randomised clinical trial: high-dose oral thiamine versus placebo for chronic fatigue in patients with quiescent inflammatory bowel disease.
Bager P, Hvas CL, Rud CL, Dahlerup JF. · · 2021 · cited 36× · PMID 33210299 · DOI 10.1111/apt.16166
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.
Bager P, Hvas CL, Rud CL, Dahlerup JF. · · 2022 · cited 9× · PMID 34592862 · DOI 10.1080/00365521.2021.1983640
B-vitamins, related vitamers, and metabolites in patients with quiescent inflammatory bowel disease and chronic fatigue treated with high dose oral thiamine.
Bager P, Hvas CL, Hansen MM, Ueland P, et al · · 2023 · cited 3× · PMID 37880581 · DOI 10.1186/s10020-023-00741-3
Thiamine-Reduced Fatigue in Quiescent Inflammatory Bowel Disease Is Linked to <i>Faecalibacterium prausnitzii</i> Abundance.
Bermúdez-Sánchez S, Bager P, Dahlerup JF, Baunwall SMD, et al · · 2025 · cited 2× · PMID 39790237 · DOI 10.1016/j.gastha.2024.08.012

Verify or expand the search:

Other trials of Thiamine

Trials testing the same drug.

NCT06326996 — Thiamine Intervention and Coronary Artery Bypass Grafting · EARLY_PHASE1 · recruiting
NCT06322212 — Type 2 Diabetes and Blood Brain Barrier Improvement · EARLY_PHASE1 · recruiting
NCT06298344 — The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease · EARLY_PHASE1 · completed
NCT03509662 — Vitamin C in Post-cardiac Arrest · Phase 2 · completed
NCT04977557 — Thiamine in Patients With Clinically Suspected Dry Beriberi · NA · completed

Other recruiting trials for Fatigue

Currently open trials in the same condition.

NCT07073963 — Virtual Patient Groups for Sarcoidosis Associated Fatigue · NA · recruiting
NCT07421960 — Investigation of the Relationship Between Periodontitis and Sleep Quality · recruiting
NCT07071324 — CF Wellness Program · NA · recruiting
NCT07386691 — Comparing Effect of Intradialytic Aerobic Exercise Versus Incentive Spirometer on Fatigue and Sleep Quality Among Hemodi · NA · active not recruiting
NCT06819254 — Pilot Study of Fisetin to Improve Fatigue Among Older Adult Cancer Survivors · Phase 4 · recruiting

Other University of Aarhus trials

Trials by the same sponsor.

NCT07209540 — European LUpuS Inception-Cohort Developing initiATivE · not yet recruiting
NCT07317401 — Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Post-Viral Myalgic Encephalo · NA · not yet recruiting
NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
NCT07528339 — Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK) · not yet recruiting
NCT07451028 — Effect of an Oral Neuromuscular Training Device on Dysphagia · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03634735 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
Last refreshed: 29 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03634735.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing