Crohn's Disease, Fatigue
Conditions
Keywords
Crohn's disease, carnitine
Brief summary
This is a randomized, double-blind, placebo-controlled study, comparing the effect of L-carnitine vs placebo on fatigue among Crohn's disease patients. The specific aim of this study is to determine if treatment with L-carnitine is more effective than placebo at decreasing fatigue severity scores, while accounting for disease activity and concomitant anemia, depression/anxiety and poor sleep quality.
Detailed description
A total of 100 patients will be recruited, in order to be able ensure to detect a significant difference in fatigue between the treatment and control groups.
Interventions
DRUGL-carnitine
dietary supplement
OTHERPlacebo
Patients will receive placebo, which will be manufactured by the same supplier as L-carnitine and appears identical. Patients will take an equal number of pills (8 pills/day).
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients will have had previously macro- and microscopically verified Crohn's disease, as defined by traditional clinical and endoscopic standards. * To be included, patients need to have disease which is either in remission or is mild to moderate in severity, as defined by the Harvey-Bradshaw Index Score (HBI\<16). * In addition, patients will need to answer yes to the screening study entry question (Is fatigue a signficant problem for you currently?).
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue severity scale | From baseline to 3 months after intervention initiation | The Fatigue Severity Score is a validated instrument to assess fatigue associated with chronic disease. The scale ranges from scores from 9 to 63, with a higher score indicated greater fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Multidimensional Fatigue Inventory | From baseline to 3 months after intevention initiation | This is a validated instrument to measure fatigue and has been validated for use for patients with inflammatory bowel disease. Scores range from 4-20, with higher scores indicated more severe fatigue. |
| Change in handgrip strength | From baseline to 3 months after treatment intervention | Handgrip strength will be assessed by a portable dynanometer. Maximal force after three tries will be recorded. |
Countries
United States
Outcome results
None listed