Study Stopped
The COVID-19 pandemic increased hospital pressure and suspended hospital visits, making it impossible to continue with recruitment. The project has been terminated.
Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain
COSENUT
1 other identifier
interventional
380
1 country
7
Brief Summary
The present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedStudy Start
First participant enrolled
November 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2022
CompletedMay 19, 2022
May 1, 2022
2.5 years
April 15, 2019
May 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (18)
Body mass index
Index for relating weight to height. Abbreviated BMI. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared
baseline
Body mass index
Index for relating weight to height. Abbreviated BMI. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared
12 weeks
Body mass index
Index for relating weight to height. Abbreviated BMI. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared
6 months
Change in nutritional status
Change in the Global Subjective Assessment (this scale categorize participants into A, B or C being A the best nutritional status and C the worst.)
from baseline-12 weeks
Change in nutritional status
Change in the Global Subjective Assessment (this scale categorize participants into A, B or C being A the best nutritional status and C the worst.)
from basal-6 months
Number of participants Diagnosed of malnutrition
Diagnosis of malnutrition using GLIM criteria
from baseline-12 weeks
Number of participants Diagnosed of malnutrition
Diagnosis of malnutrition using GLIM criteria
from baseline-6 months
Health related quality of life
EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)
from baseline-12 weeks
Health related quality of life
EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)
from baseline-6 months
Functional status
Katz index (this index categorize in one of 7 categories: A,B,C,D,E,F,G from independent for all functions (A) to dependent for all functions (G))
from baseline-12 weeks
Functional status
Katz index (this index categorize in one of 7 categories: A,B,C,D,E,F,G from independent for all functions (A) to dependent for all functions (G))
from baseline-6 months
Strength and endurance
30-second Chair Stand Test
from baseline-12 weeks
Strength and endurance
30-second Chair Stand Test
from baseline-6 months
Strength
hand grip strength test
from baseline-12 weeks
Strength
hand grip strength test
from baseline-6 months
Number of Hospital admittance
Number of admittance from randomization
at 30 days
Number of Hospital admittances
Number of admittance from randomization
from randomization to 6 months
Number of Medical doctor visits
Visits to any outpatient medical office
from randomization to 6 months
Secondary Outcomes (3)
Number of deaths
from randomization to 6 months
Number of Infections
at 6 months
Number of secondary effects related to the intervention
from randomization to 6 months
Study Arms (2)
Intervention group
EXPERIMENTALParticipants 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.
Control group
ACTIVE COMPARATORParticipants in the control group will receive nutrition advice
Interventions
Hypercaloric and high protein supplement
Eligibility Criteria
You may qualify if:
- \>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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Complejo Hospitalario Regional Reina Sofía
Córdoba, Andalusia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, Spain
Complejo Asistencial Universitario de León
León, Castille and León, 24008, Spain
Complejo Asistencial de Segovia
Segovia, Castille and León, Spain
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona, Catalonia, Spain
Hospital Universitari Joan Xxiii de Tarragona
Tarragona, Catalonia, Spain
Hospital General Nuestra Señora Del Prado
Talavera de la Reina, Toledo, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2019
First Posted
May 9, 2019
Study Start
November 20, 2019
Primary Completion
May 11, 2022
Study Completion
May 11, 2022
Last Updated
May 19, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share