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

This study is currently recruiting participants.
Verified February 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Amy Paller, Northwestern University
ClinicalTrials.gov Identifier:
NCT00879944
First received: April 10, 2009
Last updated: February 20, 2014
Last verified: February 2014

April 10, 2009
February 20, 2014
May 2009
June 2015   (final data collection date for primary outcome measure)
BMI [ Time Frame: 07/2010 ] [ Designated as safety issue: No ]
BMI [ Time Frame: 03/2010 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00879944 on ClinicalTrials.gov Archive Site
  • Blood Pressure [ Time Frame: 07/2010 ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 07/2010 ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 03/2010 ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 03/2010 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
  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.
  • Psoriasis
  • 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
  • Psoriasis
    Children ages 5-17 years old with moderate or severe plaque type psoriasis
    Interventions:
    • Other: Blood pressure
    • Other: Height
    • Other: Weight
    • Other: BMI
    • Other: Waist Circumference
  • Atopic Dermatitis Controls
    Children ages 5 to 17 years old with moderate to severe atopic dermatitis.
    Interventions:
    • Other: Blood pressure
    • Other: Height
    • Other: Weight
    • Other: BMI
    • Other: Waist Circumference
  • Healthy Controls
    Children 5-17 years of age who are healthy and seen in dermatology clinic for a non-systemic skin condition.
    Interventions:
    • Other: Blood pressure
    • Other: Height
    • Other: Weight
    • Other: BMI
    • Other: Waist Circumference
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
576
July 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
5 Years to 17 Years
Yes
Contact: Gil Abramovici, MD 312-227-6484 gabramovici@luriechildrens.org
United States,   Canada,   Chile,   Hong Kong,   Italy,   Netherlands
 
NCT00879944
AP-2009-13793
Yes
Amy Paller, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Amy S Paller, MD Northwestern University
Northwestern University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP