MalnutritionNCT05917418
Nutritional Support on Outcomes and Cost-effectiveness for Patients at Risk
A study testing nutritional support in people with Malnutrition, run by Peking Union Medical College at 2 sites in China.
Trial summary
The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- nutritional support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2026to 30 Jan 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients be in hospital overnight
- diagnoses according to the protocol of cohort study for cost effectiveness
Who cannot join
- patients admitting from emergency department
- patients who undergone operation before second morning of hospitalization
- patients who dose not give Informed Consents
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
About this study
Official title: Impact of Nutritional Support on Outcome,Cost/Effectiveness for Patient at Risk
The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness.
Read the detailed description
Although it was often to hear that malnutrition ratio in Aisa hospitalized patient was 40%-70% , there was no evidence to elaborate the prevalence of nutritional risk and malnutrition on hospitalized patients of Asia. Also in USA no data for nutritional risk. In 2002, scientists group headed by Kondrup from : European Society for Parenteral and Enteral Nutrition demonstrated that randomized controlled clinical trials showed patients may get benefit from nutrition support when they with nutrition risk. Based on these evidences, a simpler method was established by European Society for Parenteral and Enteral Nutrition in year 2002 in Munich \& it was demonstrated useful to evaluate the appropriate use of nutrition support at present time. This method was named as Nutrition Risk Screening (NRS).
Investigators propose to survey the prevalence of malnutrition \& nutrition risk in large cities' large/middle size hospitalized patients in China, Europe and USA use NRS tool. As well, we also aim to figure out the current nutrition support status in current large/middle size hospitals through this survey.
Investigators also propose to evaluate the cost-effectiveness of parenteral nutrition, enteral nutrition and non-nutritional support, and to examine the clinical outcomes of nutritional support in certain patients at nutritional risk identified by NRS-2002.
For international cooperation, the partners are Professor Kondrup of Europe and Professor Nolan from Johns Hopkins Hospital,there are students from a cooperative project with Johns Hopkins Hospital for Doctor of Philosophy students 2005-2011.
- Conditions
- Malnutrition
- Being tested
- nutritional support
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional supportDietary supplement
nutritional support
| Study group | Role | What they receive |
|---|---|---|
| Nutritional support therapy group | Experimental | All participants in this group will receive proper nutritional support. Receives: Dietary Supplement: nutritional support |
| Routine hospital management group | No intervention | All participants in this group will receive routine hospital management, without additional nutritional interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Infectious complication
A infectious complication was defined as as the presence of recognized pathogens in body tissues that normally are sterile, confirmed by the results of culture and supported by clinical, radiologic or hematologic evidence of infection
Measured: during the hospital stay
Secondary outcomes (1)
Total cost amount
The total cost amount was considered to contain 3 items in our study. The first item was the cost of nutrition support, including nutrition solutions, nursing, physician, and other staff supervision of nutrition support preparation, administration, and catheter placement and maintenance. The second item was the cost of the infectious complication.The third item was 'other costs' associated with the hospital admission, calculated from the total costs from which the cost of nutrition support and infectious complications were subtracted.
Measured: during the hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Dec 2026 (estimated)
- Primary completion30 Jan 2040 (estimated)
- Study completion30 Jan 2040 (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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu-ming Jiang, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917418
- Sponsor's protocol ID
- CMA2023CSPEN
- Status last verified
- Dec 2025
- First submitted
- 3 Jun 2023
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutritional Support on Outcome,Cost/Effectiveness for Patient at Risk
- ClinicalTrials.gov ID
- NCT05917418
- Acronym / sponsor ID
- CMA2023CSPEN
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Jan 2040 (estimated)
- Study completion
- 30 Jan 2040 (estimated)
- First posted
- 23 Jun 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 impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness.
Detailed description
Although it was often to hear that malnutrition ratio in Aisa hospitalized patient was 40%-70% , there was no evidence to elaborate the prevalence of nutritional risk and malnutrition on hospitalized patients of Asia. Also in USA no data for nutritional risk. In 2002, scientists group headed by Kondrup from : European Society for Parenteral and Enteral Nutrition demonstrated that randomized controlled clinical trials showed patients may get benefit from nutrition support when they with nutrition risk. Based on these evidences, a simpler method was established by European Society for Parenteral and Enteral Nutrition in year 2002 in Munich \& it was demonstrated useful to evaluate the appropriate use of nutrition support at present time. This method was named as Nutrition Risk Screening (NRS).
Investigators propose to survey the prevalence of malnutrition \& nutrition risk in large cities' large/middle size hospitalized patients in China, Europe and USA use NRS tool. As well, we also aim to figure out the current nutrition support status in current large/middle size hospitals through this survey.
Investigators also propose to evaluate the cost-effectiveness of parenteral nutrition, enteral nutrition and non-nutritional support, and to examine the clinical outcomes of nutritional support in certain patients at nutritional risk identified by NRS-2002.
For international cooperation, the partners are Professor Kondrup of Europe and Professor Nolan from Johns Hopkins Hospital,there are students from a cooperative project with Johns Hopkins Hospital for Doctor of Philosophy students 2005-2011.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional support therapy group | Experimental | Dietary Supplement: nutritional supportAll participants in this group will receive proper nutritional support. |
| Routine hospital management group | No intervention | –All participants in this group will receive routine hospital management, without additional nutritional interventions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients be in hospital overnight
- diagnoses according to the protocol of cohort study for cost effectiveness
Key exclusion criteria (3 listed)
- patients admitting from emergency department
- patients who undergone operation before second morning of hospitalization
- patients who dose not give Informed Consents
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 |
|---|---|---|
| nutritional supportnutritional support | Dietary supplement | Nutritional support therapy group |
Primary outcome
The incidence of Infectious complication
Time frame: during the hospital stay
A infectious complication was defined as as the presence of recognized pathogens in body tissues that normally are sterile, confirmed by the results of culture and supported by clinical, radiologic or hematologic evidence of infection
1 secondary outcome
Total cost amount
Time frame: during the hospital stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional support in people with Malnutrition, run by Peking Union Medical College at 2 sites 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
The incidence of Infectious complication (time frame: during the hospital stay). 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 9 Jan 2026.