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Completed

NCT Number: NCT00879944

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood pressure

Other

Blood pressure will be measured once while patient is seated

Height

Other

Height will be measured in centimeters at the time of enrollment

weight

Other

Weight will be measured in kilograms at enrollment

BMI

Other

Body Mass Index (BMI) will be calculated from a subject's height and weight

Waist Circumference

Other

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 outcomes

  1. BMI

    Time frame: 07/2010

Secondary outcomes

  1. Blood Pressure

    Time frame: 07/2010

  2. Waist circumference

    Time frame: 07/2010

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2009
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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