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

10 de abril de 2015 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

409

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

5 años a 17 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

  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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
BMI
Periodo de tiempo: 07/2010
07/2010

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Blood Pressure
Periodo de tiempo: 07/2010
07/2010
Waist circumference
Periodo de tiempo: 07/2010
07/2010

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Northwestern University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2009

Finalización primaria (Actual)

1 de junio de 2012

Finalización del estudio (Actual)

1 de julio de 2012

Fechas de registro del estudio

Enviado por primera vez

10 de abril de 2009

Primero enviado que cumplió con los criterios de control de calidad

10 de abril de 2009

Publicado por primera vez (Estimar)

13 de abril de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

14 de abril de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

10 de abril de 2015

Última verificación

1 de abril de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AP-2009-13793

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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