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Trial record 67 of 136 for:    AMITRIPTYLINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00728104
Recruitment Status : Withdrawn (No funding)
First Posted : August 5, 2008
Last Update Posted : February 6, 2017
Children's Hospital Los Angeles
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin

Brief Summary:
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 or disease
Cyclic Vomiting Syndrome

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Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : October 2007
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. How two vitamin supplements are being used to treat cyclic vomiting syndrome [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. How effective these supplements appear to be compared to standard treatment [ Time Frame: Two years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00728104

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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
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Principal Investigator: B Li, MD Medical College of Wiconsin

Additional Information:
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Responsible Party: B Li, Professor of Pediatrics, MD, Medical College of Wisconsin Identifier: NCT00728104    
Other Study ID Numbers: 090
First Posted: August 5, 2008    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Keywords provided by B Li, Medical College of Wisconsin:
Co-enzyme Q10
These supplements
Additional relevant MeSH terms:
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Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Coenzyme Q10
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Growth Substances