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AzTrials

MalnutritionNCT00289380

Nutrition Support on Outcomes and Cost-effectiveness for Patients at Risk

An observational study of Malnutrition and Nutritional Risk, run by Peking Union Medical College at 15 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

1. The aim of this large scale study to survey the prevalence of nutritional risk and malnutrition in China,Europe and USA. 2. The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness Already get the approval by Ethics Committee of Peking Union medical college… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Malnutrition, Nutritional Risk
Type of treatment
Injection or infusion
How many people
2,000 participants
Where
15 sitesChina
Study dates
Jan 2005to Jan 2040
Phase
Observational
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Continuing sampling in 6 clinical Departments of large, middle \& small size hospitals in 15 large cities from West, Middle \& East China. Also, data from Denmark and USA will be collected and analysed.

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

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhu-Ming Jiang, M.D., FACS contact

+86 186 0114 8800

jiangzm@imicams.ac.cn, jiangzhm@pumch.cn

Kang Yu, M.S. contact

+86 13801130457

yuk2004@gmail.com

15 sites in 1 country

China15 sites, 9 recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730

    Active, not recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Active, not recruiting

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

    Zhuo Li, 18186943979, 18186943979@163.com

    Not yet recruiting

  • Chongqing Medical Univ. Hospital

    Chongqing, Chongqing Municipality

    Completed

  • Xin Qiao Hospital

    Chongqing, Chongqing Municipality

    Hua Yang, M.D., +86 13668057773, hyang@med.umich.edu

    Hua Yang, M.D.

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Wen-hua Zhan, M.D., +86 20 87755766, wenhuazhan@medmail.com.cn

    Wen-hua Zhan, M.D.

    Recruiting

  • Second Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310006

    Active, not recruiting

  • Nanjing General Hospital of Nanjing Military Command

    Nanjing, Jiangsu, 210002

    Zhi-wei Jiang, M.D., +86 25 84619727, surgery34@163.com

    Zhi-wei Jiang, M.D.

    Recruiting

  • The First Affiliated Hospial, Guangxi Medical University

    Nanning, Guangxi, 530021

    Ning Xia, M.D., +86 771 5303201

    Ning Xia, M.D.

    Recruiting

  • Xin Hua Hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200029

    Wei Cai, M.D., +86 21 65790000, caiwei204@yahoo.com.cn

    Wei Cai, M.D.

    Recruiting

  • Sixth Hospital

    Shanghai, Shanghai Municipality

    Huai-Long Qin, M.D., hlqin@sjtu.edu.cn

    Huai-Long Qin, M.D.

    Recruiting

  • The First University Hospital, Hebei Medical University

    Shijiazhuang, Hebei, 050031

    Ru-mei Jia, M.D., +86 311 85917000, jiarm@jyyy.com.cn

    Ru-mei Jia, M.D.

    Recruiting

  • Nankai Hospital

    Tianjin, Hebei, 300100

    Active, not recruiting

  • The First Affiliated Hospital, Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

    Active, not recruiting

  • Tongji Hospital, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Yi-ping Wu, M.D., +86 27 62363420, mail@tjh.tjmu.edu.cn

    Yi-ping Wu, M.D.

    Recruiting

Other trials in China

About this study

Official title: 1. Prevalence of Nutritional Risk-undernutrition-support in China-Euro-USA. 2. Impact of Nutrition Support on Outcome for Patient at Risk. 3. Impact of Nutrition Support on Outcome,Cost/Effectiveness for Patient at Risk.

  1. The aim of this large scale study to survey the prevalence of nutritional risk and malnutrition in China,Europe and USA.
  2. The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness

Already get the approval by Ethics Committee of Peking Union medical college and Johns Hopkins Hospital.

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).

We 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.

we 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,our 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.

In plan this protocol might be completed around 2016 also.

Keywords
Nutritional Risk Screening(NRS), Malnutrition, Overweight, Obesity, Clinical nutritional support, Clinical outcome, Cost effectiveness, Complication, Infective complications
Medical subject headings
Malnutrition, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00289380
Study groupRoleWhat they receive
Nutrition supportNutrition support cohort means accept nutrition support，it was defined as ≥15kal/kg/d and < 30kal/kg/d of non-protein calories (carbohydrate and/or fat) and amino acids or protein≥1g/kg/d for 5~28 consecutive days.
Without nutritional supportGroup received only intravenous 5 to 10% glucose and electrolyte infusions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Observation will be carried from admitting end until discharge

Secondary outcomes (1)

  1. cost effectiveness

    The cost effectiveness analysis was performed from the payers' perspective.The percentage of infectious complication-free patients was used to measure the effectiveness. The total cost 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. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the costs difference between the nutrition support cohort and no-nutrition support cohort by their difference in effectiveness.

    Measured: Observation will be carried from admitting end until discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2006 (estimated)
  2. Study startJan 2005
  3. Primary completionJan 2040 (estimated)
  4. Study completionJan 2040 (estimated)

Resources

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
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00289380
Sponsor's protocol ID
CMA2005CSPEN
Status last verified
Dec 2025
First submitted
8 Feb 2006
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
No

Publications

  • Jie B, Jiang ZM, Nolan MT, Efron DT, Zhu SN, Yu K, Kondrup J. Impact of nutritional support on clinical outcome in patients at nutritional risk: a multicenter, prospective cohort study in Baltimore and Beijing teaching hospitals. Nutrition. 2010 Nov-Dec;26(11-12):1088-93. doi: 10.1016/j.nut.2009.08.027. Epub 2009 Dec 5.

    PubMed 19963351

Questions about this trial

What is this clinical trial studying?

An observational study of Malnutrition and Nutritional Risk, run by Peking Union Medical College at 15 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: looking for participants now, 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 15 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?

Contact Zhu-Ming Jiang, M.D., FACS (+86 186 0114 8800, jiangzm@imicams.ac.cn, jiangzhm@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infectious complication (time frame: Observation will be carried from admitting end until discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00289380, which also lists 1 linked publication.

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.

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