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

NCT01523106 | Withdrawn

• 1 other identifier: carnitine and crohn's disease
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease; Fatigue

Keywords

Crohn's disease; carnitine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in Multidimensional Fatigue Inventory

  From baseline to 3 months after intevention initiation

• Change in handgrip strength

  From baseline to 3 months after treatment intervention

Study Arms (2)

Carnitine

ACTIVE COMPARATOR

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

Drug: L-carnitine

Placebo

PLACEBO COMPARATOR

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

Interventions

L-carnitine DRUG

dietary supplement

Carnitine

Placebo OTHER

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).

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?").

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Medical Center, Mt. Zion Medical Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Crohn Disease; Fatigue

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Uma Mahadevan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: February 1, 2012
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

US (1)