Thiamin Against Robust IBD Fatigue

Study Overview
=================
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.

Official Title
-----------------
Thiamin Against Robust IBD Fatigue

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Drug: Thiamine
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: RCT and crossover
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thiamin<br>Oral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each. | Drug: Thiamine<br>* Vitamine B1<br>* Other names: Vitamine B1;|
| Placebo Comparator: Placebo<br>Placebo: same number of tablets as in the active comparator arm, in 4 weeks | Other: Placebo<br>* Placebo tablets<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After 4 weeks active treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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). | Week 4, 8, 12, 24, and 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory Bowel Disease, Fatigue, Thiamine, Vitamin B1