Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis

Psoriasis Clinical Trial

Official title:

Multicenter Randomized Clinical Study Evaluating the Efficacy of Dietary Intervention and Weight Loss in Improving Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714284
• Other study ID #: PSODIET1
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: February 21, 2013
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2013
• Source: Centro Studi Gised
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Bioethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a multicenter randomized controlled clinical trial evaluating the impact of a structured non pharmacological intervention consisting in intensive weight reduction (qualitative and quantitative changes in diet associated with physical exercise) compared to an intervention based on a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of chronic plaque psoriasis

• BMI > 25 Kg/m²

• Patients under systemic treatments for psoriasis or candidates for such treatments

Exclusion Criteria:

• Diagnosis of other type of psoriasis or psoriatic arthritis

• Patients under local treatments or candidates for such treatments

• Patients expected to have poor compliance at follow-up evaluation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Behavioral:
• Informative
The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.
• Diet and Exercise
The intervention consists in a 20 weeks quantitative and qualitative dietary plan for weight loss associated with physical exercise. The plan will be developed with the help of qualified staff (Dieticians) and elaborated in relation to individual needs of the patient.

Locations

Country	Name	City	State
Italy	Department of Dermatology; Bellaria-Maggiore Hospital	Bologna	Emilia Romagna
Italy	Department of Dermatology; S.Orsola-Malpighi General Hospital	Bologna	Emilia Romagna
Italy	Dermatology Department; M. Bufalini Hospital	Cesena	Emilia Romagna
Italy	Department of Dermatology; S. Anna University Hospital	Ferrara	Emilia Romagna
Italy	Department of Dermatology; G.B.Morgagni-L.Pierantoni Hospital	Forlì	Emilia Romagna
Italy	Department of Dermatology; University General Hospital of Modena	Modena	Emilia Romagna
Italy	Department of Dermatology; University General Hospital of Parma	Parma	Emilia Romagna
Italy	Department of Dermatology; Hospital of Piacenza	Piacenza	Emilia Romagna
Italy	Department of Dermatology; AUSL of Ravenna	Ravenna	Emilia Romagna
Italy	Department of Dermatology; S. Maria Nuova Hospital	Reggio Emilia	Emilia Romagna
Italy	Department of Dermatology; Infermi Hospital	Rimini	Emilia Romagna

Sponsors (2)

Lead Sponsor	Collaborator
Centro Studi Gised	Azienda Ospedaliera - Universitaria di Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any change from baseline of PASI index		20 weeks	No
Secondary	Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)		8 weeks, 16 weeks, 20 weeks	No
Secondary	Percent change from baseline of PASI index equal to 100% (PASI100)		8 weeks, 16 weeks, 20 weeks	No
Secondary	Any change from baseline of PASI index		8 weeks, 16 weeks, 20 weeks	No
Secondary	Any reduction from baseline of Body Mass Index (BMI)		8 weeks, 16 weeks, 20 weeks	No
Secondary	Any reduction from baseline of waist circumference		8 weeks, 16 weeks, 20 weeks	No
Secondary	Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)		8 weeks, 16 weeks, 20 weeks	No