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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00728104
Other study ID # 090
Secondary ID
Status Withdrawn
Phase N/A
First received July 31, 2008
Last updated February 3, 2017
Start date October 2007
Est. completion date January 2017

Study information

Verified date February 2017
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Medical College of Wisconsin Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary How two vitamin supplements are being used to treat cyclic vomiting syndrome Two years
Secondary How effective these supplements appear to be compared to standard treatment Two years
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