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Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index

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ClinicalTrials.gov Identifier: NCT00879944
Recruitment Status : Completed
First Posted : April 13, 2009
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Brief Summary:
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.

Condition or disease Intervention/treatment
Psoriasis Atopic Dermatitis Other: Blood pressure Other: Height Other: Weight Other: BMI Other: Waist Circumference

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 409 participants
Time Perspective: Prospective
Official Title: Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index and Comorbid Risk Factors: an Epidemiologic Analysis
Study Start Date : May 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Group/Cohort Intervention/treatment
Psoriasis
Children ages 5-17 years old with moderate or severe plaque type psoriasis. Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight 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
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. Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight 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
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.

Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight 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

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



Primary Outcome Measures :
  1. BMI [ Time Frame: 07/2010 ]

Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 07/2010 ]
  2. Waist circumference [ Time Frame: 07/2010 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. Children ages 5 to 17 years old with either moderate or severe plaque type psoriasis
  2. Children ages 5 to 17 years old with moderate or severe atopic dermatitis
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879944


Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92123
University of California, San Francisco
San Francisco, California, United States, 94143
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Massachusetts
UMass Memorial Dermatology Center
Worcester, Massachusetts, United States, 01605
United States, Missouri
Central Dermatology
St. Louis, Missouri, United States, 63117-1206
United States, Ohio
University Hospitals, Case Medical Centers
Cleveland, Ohio, United States, 44106
United States, Texas
Texas Dermatology Associates
Dallas, Texas, United States, 75246
Texas Children's Hospital
Houston, Texas, United States, 77030
Canada, Newfoundland and Labrador
Nexus Clinical Resarch
St. John's, Newfoundland and Labrador, Canada
Chile
Pontificia Universidad Catolica de Chile
Santiago, Chile
Hong Kong
University of Hong Kong
Tuen Mun, Hong Kong
Italy
Universita Verona
Verona, Italy
Netherlands
UMC St. Radboud
Nijmegen, Netherlands
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Amy S Paller, MD Northwestern University

Additional Information:
Publications of Results:
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
First Posted: April 13, 2009    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by Amy Paller, Northwestern University:
Psoriasis
Obesity
BMI
Atopic Dermatitis

Additional relevant MeSH terms:
Psoriasis
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases