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Trials / Completed

CompletedNCT01107197

Nutritional Support in Pressure Ulcer Patients

Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200 (actual)
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTEnriched nutrition formulaoral formula enriched in arginine, zinc and antioxidant oligoelements
DIETARY_SUPPLEMENTControl formulaIsonitrogenous isocaloric oral formula

Timeline

Start date
2010-02-01
Primary completion
2012-11-01
Completion
2012-11-01
First posted
2010-04-20
Last updated
2014-02-12
Results posted
2014-02-12

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01107197. Inclusion in this directory is not an endorsement.

Nutritional Support in Pressure Ulcer Patients (NCT01107197) · Clinical Trials Directory