search
Back to results

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

Primary Purpose

Crohn's Disease, Fatigue

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
L-carnitine
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, carnitine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSF Medical Center, Mt. Zion Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Carnitine

Placebo

Arm Description

Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months

Patients will take placebo for 3 months. Placebo is manufactured by the same company as the L-carnitine and will have a similar appearance.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in handgrip strength
Handgrip strength will be assessed by a portable dynanometer. Maximal force after three tries will be recorded.

Full Information

First Posted
January 18, 2012
Last Updated
January 16, 2014
Sponsor
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT01523106
Brief Title
L-carnitine to Treat Fatigue Associated With Crohn's Disease
Official Title
L-carnitine to Treat Fatigue Associated With Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Fatigue
Keywords
Crohn's disease, carnitine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carnitine
Arm Type
Active Comparator
Arm Description
Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will take placebo for 3 months. Placebo is manufactured by the same company as the L-carnitine and will have a similar appearance.
Intervention Type
Drug
Intervention Name(s)
L-carnitine
Intervention Description
dietary supplement
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in fatigue severity scale
Description
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.
Time Frame
From baseline to 3 months after intervention initiation
Secondary Outcome Measure Information:
Title
Change in Multidimensional Fatigue Inventory
Description
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.
Time Frame
From baseline to 3 months after intevention initiation
Title
Change in handgrip strength
Description
Handgrip strength will be assessed by a portable dynanometer. Maximal force after three tries will be recorded.
Time Frame
From baseline to 3 months after treatment intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uma Mahadevan, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Medical Center, Mt. Zion Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs