Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index
This study is currently recruiting participants.
Verified January 2013 by Northwestern University
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Amy Paller, Northwestern University
ClinicalTrials.gov Identifier:
NCT00879944
First received: April 10, 2009
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Psoriasis Atopic Dermatitis |
Other: Blood pressure Other: Height Other: Weight Other: BMI Other: Waist Circumference |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index and Comorbid Risk Factors: an Epidemiologic Analysis |
Resource links provided by NLM:
Further study details as provided by Northwestern University:
Primary Outcome Measures:
- BMI [ Time Frame: 07/2010 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Blood Pressure [ Time Frame: 07/2010 ] [ Designated as safety issue: No ]
- Waist circumference [ Time Frame: 07/2010 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 576 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Psoriasis
Children ages 5-17 years old with moderate or severe plaque type psoriasis
|
Other: Blood pressure
Blood pressure will be measured once while patient is seated
Other: Height
Height will be measured in centimeters at the time of enrollment
Other: Weight
Weight will be measured in kilograms at enrollment
Other: BMI
Body Mass Index (BMI) will be calculated from a subject's height and weight
Other: Waist Circumference
Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm
|
|
Atopic Dermatitis Controls
Children ages 5 to 17 years old with moderate to severe atopic dermatitis.
|
Other: Blood pressure
Blood pressure will be measured once while patient is seated
Other: Height
Height will be measured in centimeters at the time of enrollment
Other: Weight
Weight will be measured in kilograms at enrollment
Other: BMI
Body Mass Index (BMI) will be calculated from a subject's height and weight
Other: Waist Circumference
Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm
|
|
Healthy Controls
Children 5-17 years of age who are healthy and seen in dermatology clinic for a non-systemic skin condition.
|
Other: Blood pressure
Blood pressure will be measured once while patient is seated
Other: Height
Height will be measured in centimeters at the time of enrollment
Other: Weight
Weight will be measured in kilograms at enrollment
Other: BMI
Body Mass Index (BMI) will be calculated from a subject's height and weight
Other: Waist Circumference
Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm
|
Eligibility| Ages Eligible for Study: | 5 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
- Children ages 5 to 17 years old with either moderate or severe plaque type psoriasis
- Children ages 5 to 17 years old with moderate or severe atopic dermatitis
- Children ages 5 to 17 years old seen in dermatology clinic who are healthy and without a systemic disorder.
Criteria
Inclusion Criteria:
- Subjects must be between the ages of 5 and 17 years at the time of enrollment.
- Subjects of either sex.
- Subjects who have had psoriatic plaques for more than 6 months.
- Subjects and guardians of minors must sign the approved IRB consent form(s) prior to initiation of the study protocol.
- Subjects enrolled as "non-inflammatory" normal controls will carry a common non- systemic skin condition, such as acne, nevi, warts and molluscum as their main diagnosis.
- Subjects enrolled as "inflammatory" normal controls will carry a diagnosis of moderate to severe atopic dermatitis.
Exclusion Criteria:
- Subjects who are unable to give informed consent or assent.
- Subjects who have had psoriasis for less than 6 months.
- Subjects whose condition is deemed unsafe or incapable by the study investigator for study participation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879944
Contacts
| Contact: Lauren Becker, MD | 312-227-6485 | LRBecker@luriechildrens.org |
Locations
| United States, California | |
| University of California, San Diego | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Wynnis Tom, MD | |
| Principal Investigator: Wynnis Tom, MD | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Kelly M Cordoro, MD 415-885-7800 cordorok@derm.ucsf.edu | |
| Principal Investigator: Kelly M Cordoro, MD | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Latanya J Benjamin, MD 650-725-9051 Dr.Benjamin@stanford.edu | |
| Principal Investigator: Latanya J Benjamin, MD | |
| United States, Illinois | |
| Children's Memorial Hospital Division of Dermatology | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Katherine M Mercy, MD 773-327-3326 kmercy@childrensmemorial.org | |
| Principal Investigator: Amy S Paller, MD | |
| Sub-Investigator: Alfred Rademaker, PhD | |
| United States, Massachusetts | |
| UMass Memorial Dermatology Center | Completed |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Missouri | |
| Central Dermatology | Completed |
| St. Louis, Missouri, United States, 63117-1206 | |
| United States, Ohio | |
| University Hospitals, Case Medical Centers | Completed |
| Cleveland, Ohio, United States, 44106 | |
| United States, Texas | |
| Texas Dermatology Associates | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Alan Menter, MD 214-820-9114 amderm@gmail.com | |
| Principal Investigator: Alan Menter, MD | |
| Texas Children's Hospital | Completed |
| Houston, Texas, United States, 77030 | |
| Canada, Newfoundland and Labrador | |
| Nexus Clinical Resarch | Completed |
| St. John's, Newfoundland and Labrador, Canada | |
| Chile | |
| Pontificia Universidad Catolica de Chile | Completed |
| Santiago, Chile | |
| Hong Kong | |
| University of Hong Kong | Completed |
| Tuen Mun, Hong Kong | |
| Italy | |
| Universita Verona | Completed |
| Verona, Italy | |
| Netherlands | |
| UMC St. Radboud | Completed |
| Nijmegen, Netherlands | |
Sponsors and Collaborators
Northwestern University
Investigators
| Principal Investigator: | Amy S Paller, MD | Northwestern University |
More Information
Additional Information:
No publications provided by Northwestern University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amy Paller, Chair, Department of Dermatology, Professor of Dermatology and Pediatric Dermatology, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00879944 History of Changes |
| Other Study ID Numbers: | AP-2009-13793 |
| Study First Received: | April 10, 2009 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Psoriasis Obesity BMI Atopic Dermatitis |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Psoriasis Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Skin Diseases, Papulosquamous |
ClinicalTrials.gov processed this record on May 22, 2013