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

P

Peking Union Medical College

Status

Begins enrollment in 9 months

Conditions

Malnutrition

Treatments

Dietary Supplement: nutritional support

Study type

Interventional

Funder types

Other

Identifiers

NCT05917418
CMA2023CSPEN

Details and patient eligibility

About

The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients be in hospital overnight
  • diagnoses according to the protocol of cohort study for cost effectiveness

Exclusion criteria

  • patients admitting from emergency department
  • patients who undergone operation before second morning of hospitalization
  • patients who dose not give Informed Consents

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

400 participants in 2 patient groups

Nutritional support therapy group
Experimental group
Description:
All participants in this group will receive proper nutritional support.
Treatment:
Dietary Supplement: nutritional support
Routine hospital management group
No Intervention group
Description:
All participants in this group will receive routine hospital management, without additional nutritional interventions.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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