Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index
| Tracking Information | |||||
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| First Received Date ICMJE | April 10, 2009 | ||||
| Last Updated Date | January 31, 2013 | ||||
| Start Date ICMJE | May 2009 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
BMI [ Time Frame: 07/2010 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
BMI [ Time Frame: 03/2010 ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00879944 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index | ||||
| Official Title ICMJE | Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index and Comorbid Risk Factors: an Epidemiologic Analysis | ||||
| Brief Summary | Several environmental factors and comorbid conditions have been found to be associated with psoriasis in adults, including obesity, depression, smoking, and other cardiovascular risk factors such as high blood pressure. The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population. This is a multi-center study with a planned total enrollment of about 200 subjects ages 2-17 years old with psoriasis and 100 aged-match controls. Patient and family history will be recorded. All subjects will undergo standard height, weight, blood pressure, and waist circumference (WC). For the obese and overweight subjects we will also obtain their growth charts to attempt to correlate weight gain with psoriasis onset and progression. All data will be compiled and then statistically analyzed. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population |
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| Intervention ICMJE |
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| Publications * | Paller AS, Mercy K, Kwasny MJ, Choon SE, Cordoro KM, Girolomoni G, Menter A, Tom WL, Mahoney AM, Oostveen AM, Seyger MM. Association of pediatric psoriasis severity with excess and central adiposity: an international cross-sectional study. JAMA Dermatol. 2013 Feb;149(2):166-76. | ||||
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 576 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 17 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Canada, Chile, Hong Kong, Italy, Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00879944 | ||||
| Other Study ID Numbers ICMJE | AP-2009-13793 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Amy Paller, Northwestern University | ||||
| Study Sponsor ICMJE | Northwestern University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Northwestern University | ||||
| Verification Date | January 2013 | ||||
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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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