Crohn's DiseaseNCT01523106
L-carnitine to Treat Fatigue Associated With Crohn's Disease
A study testing L-carnitine in people with Crohn's Disease and Fatigue, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease, Fatigue
- What is being tested?
- L-carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?").
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center, Mt. Zion Medical Center
San Francisco, California, 94115
About this study
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.
Read the 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.
- Conditions
- Crohn's Disease, Fatigue
- Being tested
- L-carnitine, Placebo
- Keywords
- Crohn's disease, carnitine
- Medical subject headings
- Crohn Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDrug
dietary supplement
PlaceboOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Carnitine | Active comparator | Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 3 months after intervention initiation
Secondary outcomes (2)
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.
Measured: From baseline to 3 months after intevention initiation
Change in handgrip strength
Handgrip strength will be assessed by a portable dynanometer. Maximal force after three tries will be recorded.
Measured: From baseline to 3 months after treatment intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startAug 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uma Mahadevan, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523106
- Sponsor's protocol ID
- carnitine and crohn's disease
- Status last verified
- Jan 2014
- First submitted
- 18 Jan 2012
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-carnitine to Treat Fatigue Associated With Crohn's Disease
- ClinicalTrials.gov ID
- NCT01523106
- Acronym / sponsor ID
- carnitine and crohn's disease
- Conditions
- Crohn's Disease, Fatigue
- Keywords
- Crohn's disease, carnitine
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carnitine | Active comparator | Drug: L-carnitinePatients will take 4grams of L-carnitine (2 grams twice daily) for 3 months |
| Placebo | Placebo comparator | Other: PlaceboPatients will take placebo for 3 months. Placebo is manufactured by the same company as the L-carnitine and will have a similar appearance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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?").
Key exclusion criteria (11 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-carnitinedietary supplement | Drug | Carnitine |
| PlaceboPatients 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). | Other | Placebo |
Primary outcome
Change in fatigue severity scale
Time frame: 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.
2 secondary outcomes
Change in Multidimensional Fatigue Inventory
Time frame: From baseline to 3 months after intevention initiation
Change in handgrip strength
Time frame: From baseline to 3 months after treatment intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uma Mahadevan, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-carnitine in people with Crohn's Disease and Fatigue, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue severity scale (time frame: From baseline to 3 months after intervention initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2014.