MalnutritionNCT06062914
Health Economic Research on Oral Nutritional Supplements for Hospitalized Patients With Nutritional Risk
An observational study of Malnutrition and Nutritional Risk, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the treatment effect and health economic impact of oral nutritional supplements(ONS) in hospitalized patients with nutritional risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Nutritional Risk
- What is being tested?
- oral nutritional supplements
- Type of treatment
- Pill or oral medicine
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2023to 30 Nov 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: hospitalized patients with nutritional risk
Who may be able to join
- age≥18 years old;
- length of hospital stay ≥3days;
- Only ONS was used as enteral nutrition or no enteral nutrition was received.
Who cannot join
- age<18;
- length of hospital stay<3 days;
- the patients who received enteral nutrition other than ONS (such as tube feeding); (4) emergency admissions;
- the patients who transferred from other hospitals; (6) pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Yu Wang, +86 18382008790, med_wangyu@qq.com
About this study
The goal of this observational study is to evaluate the treatment effect and health economic impact of oral nutritional supplements(ONS) in hospitalized patients with nutritional risk. The main questions it aims to answer are:
- To evaluate the effect of ONS on clinical outcomes in hospitalized patients with high nutritional risk
- To evaluate the health economic impact of ONS in hospitalized patients with high nutritional risk Data was collected from patients admitted to peking union medical college hospital between January 1, 2018 and December 31, 2020.
Read more
The inclusion criteria were as follows: (1) age≥18 years old; (2)length of hospital stay≥3days; (3) Only ONS was used as enteral nutrition or no enteral nutrition was received.
Exclusion criteria were: (1) age<18; (2) length of hospital stay<3 days; (3) the patients who received enteral nutrition other than ONS (such as tube feeding); (4) emergency admissions; (5) the patients who transferred from other hospitals; (6) pregnancy or lactation
We collected the following data through the hospital big data query and analysis system:
- Basic information: gender, age, height, weight, medical insurance, etc.
- Clinical information: admission paths, admission time, admission departments, discharge time, discharge unit, length of stay, mode of payment；
- Disease Information: admission diagnosis, disease coding at admission, the first discharge diagnosis, the coding of first discharge diagnosis, the second discharge diagnosis, the third discharge diagnosis, outcome (recovery, improvement, not cured, death, transfer to another hospital)
- Operation information: surgical name, surgery code,
- oral nutritional supplement: drug names, unit price
- laboratory examination: hemoglobin, albumin, prealbumin
- hospitalization costs: total cost, self-pay cost, other cost, the type of medical insurance； Researchers will compare ONS group to see the clinical outcomes and health economic impact.
- Conditions
- Malnutrition, Nutritional Risk
- Being tested
- oral nutritional supplements
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral nutritional supplementsDrug
Only ONS was used as enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| oral nutritional supplement group | Only oral nutritional supplement was used as enteral nutrition, including but not limited to Ensure®, Nutrison® and etc. Receives: Drug: oral nutritional supplements | |
| no-oral nutritional supplement group | no enteral nutrition was received |
What is being measured
The primary outcome is the main question the study is designed to answer.
total cost
The total cost of hospitalization for the patient
Measured: through study completion, an average of 1 month
Secondary outcomes (1)
mortality
the number of deaths during the hospital stay
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start7 Oct 2023 (estimated)
- Primary completion7 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
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.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062914
- Sponsor's protocol ID
- CAJJ-003
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Economic Research on Oral Nutritional Supplements for Hospitalized Patients With Nutritional Risk
- ClinicalTrials.gov ID
- NCT06062914
- Acronym / sponsor ID
- CAJJ-003
- Conditions
- Malnutrition, Nutritional Risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 7 Oct 2023 (estimated)
- Primary completion
- 7 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 2 Oct 2023 (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 goal of this observational study is to evaluate the treatment effect and health economic impact of oral nutritional supplements(ONS) in hospitalized patients with nutritional risk. The main questions it aims to answer are:
- To evaluate the effect of ONS on clinical outcomes in hospitalized patients with high nutritional risk
- To evaluate the health economic impact of ONS in hospitalized patients with high nutritional risk Data was collected from patients admitted to peking union medical college hospital between January 1, 2018 and December 31, 2020.
The inclusion criteria were as follows: (1) age≥18 years old; (2)length of hospital stay≥3days; (3) Only ONS was used as enteral nutrition or no enteral nutrition was received.
Exclusion criteria were: (1) age<18; (2) length of hospital stay<3 days; (3) the patients who received enteral nutrition other than ONS (such as tube feeding); (4) emergency admissions; (5) the patients who transferred from other hospitals; (6) pregnancy or lactation
We collected the following data through the hospital big data query and analysis system:
- Basic information: gender, age, height, weight, medical insurance, etc.
- Clinical information: admission paths, admission time, admission departments, discharge time, discharge unit, length of stay, mode of payment；
- Disease Information: admission diagnosis, disease coding at admission, the first discharge diagnosis, the coding of first discharge diagnosis, the second discharge diagnosis, the third discharge diagnosis, outcome (recovery, improvement, not cured, death, transfer to another hospital)
- Operation information: surgical name, surgery code,
- oral nutritional supplement: drug names, unit price
- laboratory examination: hemoglobin, albumin, prealbumin
- hospitalization costs: total cost, self-pay cost, other cost, the type of medical insurance； Researchers will compare ONS group to see the clinical outcomes and health economic impact.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral nutritional supplement group | – | Drug: oral nutritional supplementsOnly oral nutritional supplement was used as enteral nutrition, including but not limited to Ensure®, Nutrison® and etc. |
| no-oral nutritional supplement group | – | –no enteral nutrition was received |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- hospitalized patients with nutritional risk
Key inclusion criteria (3 listed)
- age≥18 years old;
- length of hospital stay ≥3days;
- Only ONS was used as enteral nutrition or no enteral nutrition was received.
Key exclusion criteria (4 listed)
- age<18;
- length of hospital stay<3 days;
- the patients who received enteral nutrition other than ONS (such as tube feeding); (4) emergency admissions;
- the patients who transferred from other hospitals; (6) pregnancy or lactation
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 nutritional supplementsOnly ONS was used as enteral nutrition | Drug | oral nutritional supplement group |
Primary outcome
total cost
Time frame: through study completion, an average of 1 month
The total cost of hospitalization for the patient
1 secondary outcome
mortality
Time frame: through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Nutritional Risk, run by Peking Union Medical College Hospital at 1 site in China.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Wang (+86 18382008790, med_wangyu@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total cost (time frame: through study completion, an average of 1 month). 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 10 Oct 2023.