Vitamin B1 against chronic fatigue in inflammatory bowel disease

Phase 1

• Conditions: MedDRA version: 20.1Level: LLTClassification code 10066564Term: Chronic fatigueSystem Organ Class: 100000004867; Therapeutic area: Not possible to specify; Inflammatory bowel disease

• Registration Number: EUCTR2018-002324-17-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-04
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inflammatory bowel disease
Disease in remission
Chronic fatigue
Age > 17 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Co-morbidity that can explain fatigue
Non-compliant patients
Pregnancy
Possible surgical intervention

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if the levels of fatigue can be reduced after 4 weeks treatment with Thiamin, among patients with inflammatory bowel disease in remission and chronic fatigue;Secondary Objective: Investigate determinants for better fatigue levels<br><br>Investigate the long-trem effect after treatment with thiamin<br><br>Investigate the long-term effect of low dose thiamin in 12 weeks, after completing high dose thiamin treatment<br><br>Investigate changes in the patients' health-related quality of life<br><br>Investigate side effects to the treatment <br><br>Probably investigate differencies in the patinets microbiome ;Primary end point(s): Reduction in fatigue after 4 weeks treatment with high-dose thiamin;Timepoint(s) of evaluation of this end point: Week 4 or week 12, depending of the randomization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in fatigue and/or health-related quality of life<br><br>Sideeffects;Timepoint(s) of evaluation of this end point: Week 8, 12, 24, and 52