MalnutritionCOSENUTNCT03944161
Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain
A study testing Oral nutrition supplement and Nutritional advice in people with Malnutrition and Nutrition Disorders, run by Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral at 7 sites in Spain.
Trial summary
The present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Nutrition Disorders
- What is being tested?
- Oral nutrition supplement and Nutritional advice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 7 sitesSpain
- Study dates
- 20 Nov 2019to 11 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Diabetes mellitus type 1.
- Participation in any other study at the time of enrolment
- Cognitive limitations to participate in the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona, Catalonia
Complejo Hospitalario Regional Reina Sofía
Córdoba, Andalusia
Complejo Asistencial Universitario de León
León, Castille and León, 24008
Complejo Asistencial de Segovia
Segovia, Castille and León
Hospital General Nuestra Señora Del Prado
Talavera de la Reina, Toledo
Hospital Universitari Joan Xxiii de Tarragona
Tarragona, Catalonia
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon
About this study
The present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent.
Read the 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
- Malnutrition, Nutrition Disorders
- Being tested
- Oral nutrition supplement, Nutritional advice
- Keywords
- nutritional supplement, cost-effectiveness, cost-utility
- Medical subject headings
- Malnutrition, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutrition supplementDietary supplement
Hypercaloric and high protein supplement
Nutritional adviceOther
Advice given by the clinician
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Dietary Supplement: Oral nutrition supplement; Other: Nutritional advice |
| Control group | Active comparator | Participants in the control group will receive nutrition advice Receives: Other: Nutritional advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.)
Measured: 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.)
Measured: from basal-6 months
Number of participants Diagnosed of malnutrition
Diagnosis of malnutrition using GLIM criteria
Measured: from baseline-12 weeks
Number of participants Diagnosed of malnutrition
Diagnosis of malnutrition using GLIM criteria
Measured: 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)
Measured: 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)
Measured: 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))
Measured: 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))
Measured: from baseline-6 months
Strength and endurance
30-second Chair Stand Test
Measured: from baseline-12 weeks
Strength and endurance
30-second Chair Stand Test
Measured: from baseline-6 months
Strength
hand grip strength test
Measured: from baseline-12 weeks
Strength
hand grip strength test
Measured: from baseline-6 months
Number of Hospital admittance
Number of admittance from randomization
Measured: at 30 days
Number of Hospital admittances
Number of admittance from randomization
Measured: from randomization to 6 months
Number of Medical doctor visits
Visits to any outpatient medical office
Measured: from randomization to 6 months
Secondary outcomes (3)
Number of deaths
mortality registry
Measured: from randomization to 6 months
Number of Infections
Any diagnosed infection by a medical doctor
Measured: at 6 months
Number of secondary effects related to the intervention
Any undesirable effect due to the intervention
Measured: from randomization to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start20 Nov 2019
- Primary completion11 May 2022
- Study completion11 May 2022
Why it stopped: The COVID-19 pandemic increased hospital pressure and suspended hospital visits, making it impossible to continue with recruitment. The project has been terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral
- Sponsor type
- University, hospital or other
- Collaborators
- WEBER Economía y Salud S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944161
- Sponsor's protocol ID
- 01_2019
- Acronym
- COSENUT
- Status last verified
- May 2022
- First submitted
- 15 Apr 2019
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain
- ClinicalTrials.gov ID
- NCT03944161
- Acronym / sponsor ID
- COSENUT / 01_2019
- Conditions
- Malnutrition, Nutrition Disorders
- Keywords
- nutritional supplement, cost-effectiveness, cost-utility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The COVID-19 pandemic increased hospital pressure and suspended hospital visits, making it impossible to continue with recruitment. The project has been terminated.
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición EnteralUniversity, hospital or other
- Collaborators
- WEBER Economía y Salud S.L.
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Oral nutrition supplement, Other: Nutritional adviceParticipants 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 comparator | Other: Nutritional adviceParticipants in the control group will receive nutrition advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- >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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral nutrition supplementHypercaloric and high protein supplement | Dietary supplement | Intervention group |
| Nutritional adviceAdvice given by the clinician | Other | Control group, Intervention group |
Primary outcome
Body mass index
Time frame: baseline
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
Body mass index
Time frame: 12 weeks
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
Body mass index
Time frame: 6 months
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
Change in nutritional status
Time frame: from baseline-12 weeks
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.)
Change in nutritional status
Time frame: from basal-6 months
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.)
Number of participants Diagnosed of malnutrition
Time frame: from baseline-12 weeks
Diagnosis of malnutrition using GLIM criteria
Number of participants Diagnosed of malnutrition
Time frame: from baseline-6 months
Diagnosis of malnutrition using GLIM criteria
Health related quality of life
Time frame: from baseline-12 weeks
EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)
Health related quality of life
Time frame: from baseline-6 months
EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)
Functional status
Time frame: from baseline-12 weeks
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))
Functional status
Time frame: from baseline-6 months
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))
Strength and endurance
Time frame: from baseline-12 weeks
30-second Chair Stand Test
Strength and endurance
Time frame: from baseline-6 months
30-second Chair Stand Test
Strength
Time frame: from baseline-12 weeks
hand grip strength test
Strength
Time frame: from baseline-6 months
hand grip strength test
Number of Hospital admittance
Time frame: at 30 days
Number of admittance from randomization
Number of Hospital admittances
Time frame: from randomization to 6 months
Number of admittance from randomization
Number of Medical doctor visits
Time frame: from randomization to 6 months
Visits to any outpatient medical office
3 secondary outcomes
Number of deaths
Time frame: from randomization to 6 months
Number of Infections
Time frame: at 6 months
Number of secondary effects related to the intervention
Time frame: from randomization to 6 months
Results and safety
The study was stopped early (reason given: The COVID-19 pandemic increased hospital pressure and suspended hospital visits, making it impossible to continue with recruitment. The project has been terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral nutrition supplement and Nutritional advice in people with Malnutrition and Nutrition Disorders, run by Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The COVID-19 pandemic increased hospital pressure and suspended hospital visits, making it impossible to continue with recruitment. The project has been terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.