Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index
10 aprile 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Effettivo)
409
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canada
- Nexus Clinical Resarch
-
-
-
-
-
Santiago, Chile
- Pontificia Universidad Catolica de Chile
-
-
-
-
-
Tuen Mun, Hong Kong
- University of Hong Kong
-
-
-
-
-
Verona, Italia
- Universita Verona
-
-
-
-
-
Nijmegen, Olanda
- UMC St. Radboud
-
-
-
-
California
-
San Diego, California, Stati Uniti, 92123
- University of California, San Diego
-
San Francisco, California, Stati Uniti, 94143
- University of California, San Francisco
-
Stanford, California, Stati Uniti, 94305
- Stanford University School of Medicine
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60611
- Ann & Robert H Lurie Children's Hospital of Chicago
-
-
Massachusetts
-
Worcester, Massachusetts, Stati Uniti, 01605
- UMass Memorial Dermatology Center
-
-
Missouri
-
St. Louis, Missouri, Stati Uniti, 63117-1206
- Central Dermatology
-
-
Ohio
-
Cleveland, Ohio, Stati Uniti, 44106
- University Hospitals, Case Medical Centers
-
-
Texas
-
Dallas, Texas, Stati Uniti, 75246
- Texas Dermatology Associates
-
Houston, Texas, Stati Uniti, 77030
- Texas Children's Hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 5 anni a 17 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
- Children ages 5 to 17 years old with either moderate or severe plaque type psoriasis
- Children ages 5 to 17 years old with moderate or severe atopic dermatitis
- Children ages 5 to 17 years old seen in dermatology clinic who are healthy and without a systemic disorder.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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
|
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
|
|
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
|
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
|
|
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 |
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
BMI
Lasso di tempo: 07/2010
|
07/2010
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Blood Pressure
Lasso di tempo: 07/2010
|
07/2010
|
|
Waist circumference
Lasso di tempo: 07/2010
|
07/2010
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2009
Completamento primario (Effettivo)
1 giugno 2012
Completamento dello studio (Effettivo)
1 luglio 2012
Date di iscrizione allo studio
Primo inviato
10 aprile 2009
Primo inviato che soddisfa i criteri di controllo qualità
10 aprile 2009
Primo Inserito (Stima)
13 aprile 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
14 aprile 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 aprile 2015
Ultimo verificato
1 aprile 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AP-2009-13793
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .