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

NCT00728104 | Withdrawn

• 1 other identifier: 090
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cyclic Vomiting Syndrome

Keywords

Learn; L-Carnitine; Co-enzyme Q10; Effective; These supplements; Compared; Standard

Outcome Measures

Primary Outcomes (1)

• How two vitamin supplements are being used to treat cyclic vomiting syndrome

  Two years

Secondary Outcomes (1)

• How effective these supplements appear to be compared to standard treatment

  Two years

Study Arms (4)

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• discrete episodes of vomiting
• normal health between episodes
• stereotypical clinical pattern

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital Los Angeles: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• Cyclic Vomiting Syndrome Association

MeSH Terms

Conditions

Familial cyclic vomiting syndrome

Study Officials

• B Li, MD

  Medical College of Wiconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, MD

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 5, 2008
• Study Start: October 1, 2007
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 6, 2017

Record last verified: 2017-02

Locations

US (1)