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: January 3, 2014
Last verified: January 2014

July 31, 2008
January 3, 2014
October 2007
Not Provided
How two vitamin supplements are being used to treat cyclic vomiting syndrome [ Time Frame: Two years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Same as current
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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
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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
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
500
December 2014
Not Provided

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)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00728104
090
No
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
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP