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| Sponsor: | Medical College of Wisconsin |
|---|---|
| Collaborator: |
Children's Hospital and Health System Foundation, Wisconsin |
| Information provided by: | Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00727974 |
Purpose
The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS), various phenotypes of CVS (e.g. menstrual, Sato, calendar-tied) and migraine headaches (e.g. with aura, without aura, hemiplegic migraine). This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. This research is being done because many unanswered questions remain regarding children with CVS.
| Condition |
|---|
|
Vomiting Syndrome Migraines |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Genetic Analysis of Children With Cyclic Vomiting Syndrome and Migraines |
5 ml of blood will be drawn through venipucture from the study subjects, their biological parents and siblings when available. In addition, 4 ml of blood will be drawn for serologic testing.
| Estimated Enrollment: | 880 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2010 |
| Groups/Cohorts |
|---|
|
1
Diagnostic Criteria for CVS: 3 or more different episodes of vomiting, normal health between episodes, no abnormal test results to account for vomiting [such as endoscopic biopsies (looking at a body part with a lighted tube), hydronephrosis (water block kidney drainage), cholelithiasis (gallstones), pancreatitis (swelling of the pancreas), and hypoglycemia (too little sugar in the blood)]; |
|
2
Diagnostic Criteria for Migraine: 5 or more different headaches, complete return to health in between headaches, headaches last 2-48 hours and get in the way everyday activity, headache affects one side of head, with pounding moderate-to-severe pain, one of the following: nausea, vomiting, photophobia (fear of light), phonophobia (fear of sound). |
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Cyclic vomiting syndrome (CVS) may be the most severe recurrent vomiting disorder in humans. CVS is characterized by a sudden onset of rapid-fire vomiting, usually beginning in the early morning hours or upon wakening. It has a peak vomiting intensity of every 5-10 minutes (6-12 emeses) and episodes last between 2 hours and 10 days. These episodes of acute vomiting occur on average once every 2 to 4 weeks. The child returns to completely normal health between vomiting episodes. Children are diagnosed based on their specific vomiting pattern and a lack of positive findings on laboratory testing.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Wisconsin | |
| Children's Hospital of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: B Li, MD 414-266-3690 bli@mcw.edu | |
| Principal Investigator: B Li, MD | |
| Principal Investigator: | B UK Li, MD | Medical College of Wiconsin |
More Information
| Responsible Party: | B Li, Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00727974 History of Changes |
| Other Study ID Numbers: | 08/24, GC 607 |
| Study First Received: | July 31, 2008 |
| Last Updated: | January 14, 2010 |
| Health Authority: | United States: Institutional Review Board |
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Genome Wide Scan (GWS) Mitochondrial scan Family trios |
|
Vomiting Migraine Disorders Signs and Symptoms, Digestive Signs and Symptoms Headache Disorders, Primary |
Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
