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

This study has been withdrawn prior to enrollment.
(No funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00728104
First Posted: August 5, 2008
Last Update Posted: February 6, 2017
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.
Collaborator:
Children's Hospital Los Angeles
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin
July 31, 2008
August 5, 2008
February 6, 2017
October 2007
January 2017   (Final data collection date for primary outcome measure)
How two vitamin supplements are being used to treat cyclic vomiting syndrome [ Time Frame: Two years ]
Same as current
Complete list of historical versions of study NCT00728104 on ClinicalTrials.gov Archive Site
How effective these supplements appear to be compared to standard treatment [ Time Frame: Two years ]
Same as current
Not Provided
Not Provided
 
The Use of L-Carnitine And CoQ10 Supplements In the Treatment of Cyclic Vomiting Syndrome (CVS)
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.
Not Provided
Observational
Observational Model: Family-Based
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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.
Cyclic Vomiting Syndrome
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2017
January 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00728104
090
No
Not Provided
Not Provided
B Li, Medical College of Wisconsin
Medical College of Wisconsin
Children's Hospital Los Angeles
Principal Investigator: B Li, MD Medical College of Wiconsin
Medical College of Wisconsin
February 2017