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

NCT ID: NCT00728104

Last Updated: 2017-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cyclic Vomiting Syndrome

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

2

The Co-Enzyme Q10 Questionnaire: to be completed by individuals who ever taken co-enzyme Q10

No interventions assigned to this group

3

The L-Carnitine Questionnaire: to be completed by individuals who have ever taken L-carnitine

No interventions assigned to this group

4

The Amitriptyline Questionnaire: to be completed by individuals who have ever taken amitriptyline

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 3 discrete episodes of vomiting
* normal health between episodes
* stereotypical clinical pattern

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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B Li

Professor of Pediatrics, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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B Li, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wiconsin

Locations

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Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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http://www.cvsaonline.org

Cyclic Vomiting Syndrome Association

Other Identifiers

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090

Identifier Type: -

Identifier Source: org_study_id

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