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Nutritional Support in Pressure Ulcer Patients

NCT01107197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-02-12

Study results available
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Summary

Pressure ulcers are frequently associated with malnutrition. Previous studies have reported that nutritional support can improve the healing rate of pressure ulcers but no attention has been clearly given to the nutritional status of the patient treated. Moreover, other investigators have suggested the additional healing power of some nutrients. Unfortunately, previous results have been unpowered by small sample size, poor monitoring of compliance to treatments and the confounding effect of other nutrients. The investigators aimed to test the effect and additional benefits of several micronutrients delivered through oral nutritional support on the healing rate of pressure ulcers in malnourished patients.

Conditions

  • Pressure Ulcers

Interventions

DIETARY_SUPPLEMENT

Enriched nutrition formula

oral formula enriched in arginine, zinc and antioxidant oligoelements

DIETARY_SUPPLEMENT

Control formula

Isonitrogenous isocaloric oral formula

Sponsors & Collaborators

  • Nutricia, Inc.

    collaborator INDUSTRY

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    lead OTHER

Principal Investigators

  • Federico D'Andrea, MD · Azienda Ospedaliero Universitaria Maggiore della Carita

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01107197 on ClinicalTrials.gov