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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01137188 |
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Date of registration:
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18/03/2010 |
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Primary sponsor: |
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Public title:
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Effect of Weight Loss on Psoriasis
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Scientific title:
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Effect of Weight Loss on Skin Manifestations, Inflammatory Markers and Risk Factor for Comorbidity in Obese Patients With Psoriasis - a Randomized Cross-over Study |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01137188 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Lone Skov, MD, phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Copenhagen University Hospital Gentofte, Department of Dermato-venerology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- moderate/severe psoriasis at inclusion or previous to systemic immunosuppressive
therapy
- BMI > 27
Exclusion Criteria:
- pregnancy/breast feeding
- diabetes requiring insulin treatment
- severe heart/kidney/liver disease
- gout
- high potassium intake
- obesity due to medical conditions/medications
- use of medical treatment for obesity
- previous bariatric surgery
- intentional/unintentional weight loss up to 3 months prior to inclusion
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Intervention(s)
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Dietary Supplement: Low calorie diet
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Primary Outcome(s)
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PASI
[Time Frame: 12 weeks]
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PASI
[Time Frame: 16 weeks]
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PASI
[Time Frame: 4 weeks]
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PASI
[Time Frame: 8 weeks]
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PASI
[Time Frame: Baseline]
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Secondary Outcome(s)
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Risk factors for comorbidity
[Time Frame: 12 weeks]
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Risk factors for comorbidity
[Time Frame: 16 weeks]
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Risk factors for comorbidity
[Time Frame: 4 weeks]
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Risk factors for comorbidity
[Time Frame: 8 weeks]
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Risk factors for comorbidity
[Time Frame: Baseline]
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Secondary ID(s)
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H-2-2010-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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