- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00728104
The Use of L-Carnitine And CoQ10 Supplements In the Treatment of Cyclic Vomiting Syndrome (CVS)
February 3, 2017 updated by: B Li, Medical College of Wisconsin
Co-Enzyme Q10, L-Carnitine and Amitriptyline Usage in Cyclic Vomiting Syndrome (CVS): A Research Study
This is a study with the principle goal being to learn about the use of L-Carnitine and CoQ10, two vitamin supplements that are currently being used to treat Cyclic Vomiting Syndrome, largely initiated by parents.
We want to learn how effective these supplements are compared to standard treatment, at what dose, and what onset of action in order to initiate future prospective study on these supplements.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Cyclic Vomiting Syndrome (CVS) is a condition where children and adults have repeated attacks of severe vomiting, nausea, abdominal pain, headaches, and tiredness.
These episodes can last from several hours to several days.
Description
Inclusion Criteria:
- 3 discrete episodes of vomiting
- normal health between episodes
- stereotypical clinical pattern
- no abnormal test results to account for vomiting (see exclusion criteria)
Exclusion Criteria:
- abnormal UGI with small bowel follow-through revealing an anatomic anomaly, inflammatory or obstructive
- Significantly abnormal endoscopic biopsies (moderate to severe esophagitis, H. pylori)
- Abnormal abdominal ultrasound revealing hydronephrosis, cholelithiasis, pancreatitis
- Positive screening for endocrine disorder (diabetic ketoacidosis, Addison's)
- Positive screening for inborn errors of metabolism (hypoglycemia, lactic acidosis, hyperammonemia, organic acidemia, amino aciduria, elevated beta-ALA, porphobilinogen)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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1
The General Questionnaire: help to understand which characteristics of CVS patients are associated with both beneficial and harmful effects of these treatments
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2
The Co-Enzyme Q10 Questionnaire: to be completed by individuals who ever taken co-enzyme Q10
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3
The L-Carnitine Questionnaire: to be completed by individuals who have ever taken L-carnitine
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4
The Amitriptyline Questionnaire: to be completed by individuals who have ever taken amitriptyline
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
How two vitamin supplements are being used to treat cyclic vomiting syndrome
Time Frame: Two years
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Two years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
How effective these supplements appear to be compared to standard treatment
Time Frame: Two years
|
Two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: B Li, MD, Medical College of Wiconsin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Anticipated)
January 1, 2017
Study Completion (Anticipated)
January 1, 2017
Study Registration Dates
First Submitted
July 31, 2008
First Submitted That Met QC Criteria
August 4, 2008
First Posted (Estimate)
August 5, 2008
Study Record Updates
Last Update Posted (Estimate)
February 6, 2017
Last Update Submitted That Met QC Criteria
February 3, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 090
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cyclic Vomiting Syndrome
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Medical College of WisconsinCompletedCyclic Vomiting Syndrome
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Ohio State UniversityRecruitingCyclic Vomiting SyndromeUnited States
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The Cleveland ClinicCompletedCyclic Vomiting SyndromeUnited States
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Alexza Pharmaceuticals, Inc.CompletedCyclic Vomiting SyndromeUnited States
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Medical College of WisconsinCompletedCyclic Vomiting Syndrome | Abdominal MigraineUnited States
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Spectrum Health - LakelandTerminated
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