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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Children's Hospital Los Angeles
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00728104
First received: July 31, 2008
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  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
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:

U.S. FDA Resources

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 2013
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

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

No publications provided

Responsible Party: B Li, Professor of Pediatrics, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00728104     History of Changes
Other Study ID Numbers: 090
Study First Received: July 31, 2008
Last Updated: September 13, 2012
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

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Amitriptyline
Carnitine
Ubiquinone
Coenzyme Q10
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013