The Use of L-Carnitine And CoQ10 Supplements In the Treatment of Cyclic Vomiting Syndrome (CVS)
This study is enrolling participants by invitation only.
Sponsor:
Medical College of Wisconsin
Collaborator:
Children's Hospital Los Angeles
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00728104
First received: July 31, 2008
Last updated: September 13, 2012
Last verified: September 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 31, 2008 | ||||
| Last Updated Date | September 13, 2012 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
How two vitamin supplements are being used to treat cyclic vomiting syndrome [ Time Frame: Two years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00728104 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
How effective these supplements appear to be compared to standard treatment [ Time Frame: Two years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Use of L-Carnitine And CoQ10 Supplements In the Treatment of Cyclic Vomiting Syndrome (CVS) | ||||
| Official Title ICMJE | Co-Enzyme Q10, L-Carnitine and Amitriptyline Usage in Cyclic Vomiting Syndrome (CVS): A Research Study | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Family-Based Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Cyclic Vomiting Syndrome | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | December 2013 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00728104 | ||||
| Other Study ID Numbers ICMJE | 090 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | B Li, Medical College of Wisconsin | ||||
| Study Sponsor ICMJE | Medical College of Wisconsin | ||||
| Collaborators ICMJE | Children's Hospital Los Angeles | ||||
| Investigators ICMJE |
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| Information Provided By | Medical College of Wisconsin | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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