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

Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral

Status: Terminated

Conditions: Nutrition Disorders; Malnutrition

Treatments: Dietary Supplement: Oral nutrition supplement; Other: Nutritional advice

Study type: Interventional

Funder types: Other

Identifiers

NCT03944161

01_2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 380 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 y
• Nutritional status B or C (GSA criteria)
• Presenting one of the following conditions:
• Cancer patient after surgery, radiotherapy on antineoplastic treatment.
• Hip fracture
• Heart failure NYHA (New York Heart Association) III-IV.
• Breathing failure GOLD 3 o 4: FEV1 (forced expiratory volume at one second ) <50%.
• Renal failure GFR<30 (glomerular filtration rate )
• Participants agreeing the informed consent

Exclusion criteria

• Cancer patients: esophagus, stomach, pancreas and Head and neck
• Hospital admitted patients at the time of recruitment
• Life expectancy below 3 months
• Pregnant or nursing women
• Use of oral nutritional supplements in the three months prior the enrolment
• History of allergy to oral nutritional supplements
• Diabetes mellitus type 1.
• Participation in any other study at the time of enrolment
• Cognitive limitations to participate in the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

Intervention group

Experimental group

Description:

Participants in the intervention group will receive an oral nutrition supplement bottle (200/220 ml) with \>20 % of protein and 1.5 Kcal/ml without fibre twice a day during 12 weeks and nutritional advice.

Treatment:

Other: Nutritional advice

Dietary Supplement: Oral nutrition supplement

Control group

Active Comparator group

Description:

Participants in the control group will receive nutrition advice

Treatment:

Other: Nutritional advice