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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01523106
First received: January 18, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Crohn's Disease
Fatigue
Drug: L-carnitine
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: L-carnitine to Treat Fatigue Associated With Crohn's Disease

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in fatigue severity scale [ Time Frame: From baseline to 3 months after intervention initiation ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Multidimensional Fatigue Inventory [ Time Frame: From baseline to 3 months after intevention initiation ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to 3 months after treatment intervention ] [ Designated as safety issue: No ]
    Handgrip strength will be assessed by a portable dynanometer. Maximal force after three tries will be recorded.


Enrollment: 0
Study Start Date: August 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Carnitine
Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months
Drug: L-carnitine
dietary supplement
Placebo Comparator: Placebo
Patients will take placebo for 3 months. Placebo is manufactured by the same company as the L-carnitine and will have a similar appearance.
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523106

Locations
United States, California
UCSF Medical Center, Mt. Zion Medical Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Uma Mahadevan, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01523106     History of Changes
Other Study ID Numbers: carnitine and crohn's disease
Study First Received: January 18, 2012
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Crohn's disease
carnitine

Additional relevant MeSH terms:
Crohn Disease
Fatigue
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Signs and Symptoms
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014