Clinical Trials Directory

Trials / Terminated

TerminatedNCT03944161

Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
380 (actual)
Sponsor
Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent.

Detailed description

COSNUT pretends to assess the cost-effectiveness and cost-utility of oral nutritional supplementation (ONS) in persons with malnutrition and other clinical conditions. The effectiveness will be evaluated by comparing the intervention group having ONS vs a control group only with nutrition advice. The effectiveness and resource use will be collected using quality of life assessment tools, body mass index, change in malnutrition state, number of hospital admissions, medical visits... Unitary costs for Spain will be extracted from databases and official publications and will be applied to the number of resources used in order to calculate the costs in each of the groups. Finally, the incremental cost-effectiveness ratio will be estimated and presented.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTOral nutrition supplementHypercaloric and high protein supplement
OTHERNutritional adviceAdvice given by the clinician

Timeline

Start date
2019-11-20
Primary completion
2022-05-11
Completion
2022-05-11
First posted
2019-05-09
Last updated
2022-05-19

Locations

7 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT03944161. Inclusion in this directory is not an endorsement.