The Use of L-Carnitine And CoQ10 Supplements In the Treat... | NCT00728104

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

NCT00728104

Sponsor

Medical College of Wisconsin

Status

Withdrawn

Last Update Posted

Feb 6, 2017Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Cyclic Vomiting Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No funding

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jan 2017Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Jul 31, 2008

First Submission Date that Met QC Criteria

Aug 4, 2008

First Posted Date

Aug 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2017

Last Update Posted Date

Feb 6, 2017Estimated

Name	Class
Children's Hospital Los Angeles	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
How effective these supplements appear to be compared to standard treatment		Two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
B Li, MD	Medical College of Wiconsin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Wisconsin		Milwaukee	Wisconsin	53226	United States