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

April 10, 2015 updated by: Amy Paller, Northwestern University

Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index and Comorbid Risk Factors: an Epidemiologic Analysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

409

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BMI
Time Frame: 07/2010
07/2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure
Time Frame: 07/2010
07/2010
Waist circumference
Time Frame: 07/2010
07/2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

April 10, 2009

First Submitted That Met QC Criteria

April 10, 2009

First Posted (Estimate)

April 13, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP-2009-13793

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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