The Use of L-Carnitine And CoQ10 Supplements In the Treatment of Cyclic Vomiting Syndrome (CVS) - Full Text View

Sponsors and Collaborators:	Medical College of Wisconsin Children's Hospital Los Angeles
Information provided by:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00728104

Purpose

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.

Condition
Vomiting Syndrome

MedlinePlus related topics: Dietary Supplements Nausea and Vomiting

Drug Information available for: Amitriptyline Amitriptyline hydrochloride Carnitine Coenzyme Q10

U.S. FDA Resources

Study Type:	Observational
Study Design:	Family-Based, Prospective
Official Title:	Co-Enzyme Q10, L-Carnitine and Amitriptyline Usage in Cyclic Vomiting Syndrome (CVS): A Research Study

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:

How two vitamin supplements are being used to treat cyclic vomiting syndrome [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

How effective these supplements appear to be compared to standard treatment [ Time Frame: Two years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2008

Groups/Cohorts
1 The General Questionnaire: help to understand which characteristics of CVS patients are associated with both beneficial and harmful effects of these treatments
2 The Co-Enzyme Q10 Questionnaire: to be completed by individuals who ever taken co-enzyme Q10
3 The L-Carnitine Questionnaire: to be completed by individuals who have ever taken L-carnitine
4 The Amitriptyline Questionnaire: to be completed by individuals who have ever taken amitriptyline

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728104

Locations

United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Medical College of Wisconsin

Children's Hospital Los Angeles

Investigators

Principal Investigator:

B Li, MD

Medical College of Wiconsin

More Information

Cyclic Vomiting Syndrome Association This link exits the ClinicalTrials.gov site

Responsible Party:	University of Southern California: Keck School of Medicine ( Richard Boles, MD/ Director of Clinical Genetics )
Study ID Numbers:	090
Study First Received:	July 31, 2008
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00728104
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:

Learn
L-Carnitine
Co-enzyme Q10
Effective

These supplements
Compared
Standard

Study placed in the following topic categories:

Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Ubiquinone

Amitriptyline
Cyclic vomiting syndrome
Carnitine
Coenzyme Q10

Additional relevant MeSH terms:

Vitamin B Complex
Pathologic Processes
Disease
Growth Substances
Vitamins

Syndrome
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009