- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00879944
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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Santiago, Chile
- Pontificia Universidad Católica de Chile
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Nijmegen, Holandia
- UMC St. Radboud
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Tuen Mun, Hongkong
- University of Hong Kong
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Kanada
- Nexus Clinical Resarch
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California
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San Diego, California, Stany Zjednoczone, 92123
- University of California, San Diego
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San Francisco, California, Stany Zjednoczone, 94143
- University of California, San Francisco
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Stanford, California, Stany Zjednoczone, 94305
- Stanford University School of Medicine
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60611
- Ann & Robert H Lurie Children's Hospital of Chicago
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Massachusetts
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Worcester, Massachusetts, Stany Zjednoczone, 01605
- UMass Memorial Dermatology Center
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Missouri
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St. Louis, Missouri, Stany Zjednoczone, 63117-1206
- Central Dermatology
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44106
- University Hospitals, Case Medical Centers
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Texas
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Dallas, Texas, Stany Zjednoczone, 75246
- Texas Dermatology Associates
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Houston, Texas, Stany Zjednoczone, 77030
- Texas Children's Hospital
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Verona, Włochy
- Universita Verona
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
- 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.
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
---|---|
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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
---|---|
BMI
Ramy czasowe: 07/2010
|
07/2010
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
---|---|
Blood Pressure
Ramy czasowe: 07/2010
|
07/2010
|
Waist circumference
Ramy czasowe: 07/2010
|
07/2010
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- AP-2009-13793
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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