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

This study is enrolling participants by invitation only.
Children's Hospital Los Angeles
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin Identifier:
First received: July 31, 2008
Last updated: May 2, 2016
Last verified: May 2016
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.

Cyclic Vomiting Syndrome

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

Resource links provided by NLM:

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 ]

Estimated Enrollment: 500
Study Start Date: October 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
The General Questionnaire: help to understand which characteristics of CVS patients are associated with both beneficial and harmful effects of these treatments
The Co-Enzyme Q10 Questionnaire: to be completed by individuals who ever taken co-enzyme Q10
The L-Carnitine Questionnaire: to be completed by individuals who have ever taken L-carnitine
The Amitriptyline Questionnaire: to be completed by individuals who have ever taken amitriptyline


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.

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
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Please refer to this study by its identifier: NCT00728104

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
Principal Investigator: B Li, MD Medical College of Wiconsin
  More Information

Additional Information:
Responsible Party: B Li, Professor of Pediatrics, MD, Medical College of Wisconsin Identifier: NCT00728104     History of Changes
Other Study ID Numbers: 090 
Study First Received: July 31, 2008
Last Updated: May 2, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Co-enzyme Q10
These supplements

Additional relevant MeSH terms:
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Coenzyme Q10
Growth Substances
Physiological Effects of Drugs
Vitamins processed this record on May 26, 2016