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

Overview

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.

Full Title of Study: “Co-Enzyme Q10, L-Carnitine and Amitriptyline Usage in Cyclic Vomiting Syndrome (CVS): A Research Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2017

Arms, Groups and 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

Clinical Trial Outcome Measures

Primary Measures

  • How two vitamin supplements are being used to treat cyclic vomiting syndrome
    • Time Frame: Two years

Secondary Measures

  • How effective these supplements appear to be compared to standard treatment
    • Time Frame: Two years

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical College of Wisconsin
  • Collaborator
    • Children’s Hospital Los Angeles
  • Provider of Information About this Clinical Study
    • Principal Investigator: B Li, Professor of Pediatrics, MD – Medical College of Wisconsin
  • Overall Official(s)
    • B Li, MD, Principal Investigator, Medical College of Wiconsin

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