L-carnitine to Treat Fatigue Associated With Crohn's Disease

Fatigue Clinical Trial

Official title:

L-carnitine to Treat Fatigue Associated With Crohn's Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01523106
• Other study ID #: carnitine and crohn's disease
• Status: Withdrawn
• Phase: N/A
• First received: January 18, 2012
• Last updated: January 16, 2014
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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:

• Exclusion criteria will include:

• age <18 or >70 years

• pregnancy or delivery within 6 months

• malignancy diagnosed within 1 year

• oral/intravenous steroid treatment within 6 months

• any surgery within 6 months

• presence of a stoma or ileo-anal J-pouch anastomosis

• concurrent hepatitis B or C infection

• cirrhosis

• renal insufficiency (CrCl<60) and history of seizure disorder or hypothyrodism.

• prior to study enrollment

• women of child-bearing age will need to undergo pregnancy testing.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Fatigue

Intervention

Drug:
• L-carnitine
dietary supplement

Other:
• Placebo
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).

Locations

Country	Name	City	State
United States	UCSF Medical Center, Mt. Zion Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fatigue severity scale	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.	From baseline to 3 months after intervention initiation	No
Secondary	Change in Multidimensional Fatigue Inventory	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.	From baseline to 3 months after intevention initiation	No
Secondary	Change in handgrip strength	Handgrip strength will be assessed by a portable dynanometer. Maximal force after three tries will be recorded.	From baseline to 3 months after treatment intervention	No