NCT06510712

Brief Summary

Neurology disorders are one of the major public health problems that seriously threaten human health. It often accompanied by various nutritional problems, which can aggravate the primary disease, lead to serious complications, prolong the hospitalization, lead to poor prognosis, and increase family and social economic burdens. According to the previous studies, the risk of malnutrition was approximately 58.5% of stroke patients, and 6% had moderate to severe malnutrition in China. Another study conducted in Beijing showed that the risk of malnutrition of elderly patients in the department of neurology was significantly higher than in other departments (28.5% vs. 26.4%). Strengthening nutritional supervision of patients with neurology disorders will benefit to improve patients' prognosis. Therefore, the aim of this study is to investigate the nutritional status of inpatients with neurology disorders in China, evaluate the impact of different nutritional status on patients' health outcomes, and establish a high-quality, standardized nutrition and health cohort database for neurology disorders.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2024Jun 2026

First Submitted

Initial submission to the registry

July 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1.7 years

First QC Date

July 14, 2024

Last Update Submit

July 14, 2024

Conditions

Keywords

nutritionthe risk of malnutrition

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Mortality defined as all-cause mortality from inclusion to day 30

    30 days

Secondary Outcomes (5)

  • ICU admission

    30 days

  • Non-elective hospital readmission

    30 days

  • Major complications

    30 days

  • Decline in functional status of 10% or more

    30 days

  • length of in hospital days

    30 days

Other Outcomes (1)

  • Adverse events

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with the primary diagnosis are neurological disoders

You may qualify if:

  • Age ≥ 18 years;
  • The primary diagnosis was neurological disorders;
  • Written informed consent.

You may not qualify if:

  • Life expectancy is \< 3 months;
  • Researchers think other ineligible participant for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

    PMID: 34487721BACKGROUND
  • Wang YJ, Li ZX, Gu HQ, Zhai Y, Jiang Y, Zhao XQ, Wang YL, Yang X, Wang CJ, Meng X, Li H, Liu LP, Jing J, Wu J, Xu AD, Dong Q, Wang D, Zhao JZ; China Stroke Statistics 2019 Writing Committee. China Stroke Statistics 2019: A Report From the National Center for Healthcare Quality Management in Neurological Diseases, China National Clinical Research Center for Neurological Diseases, the Chinese Stroke Association, National Center for Chronic and Non-communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention and Institute for Global Neuroscience and Stroke Collaborations. Stroke Vasc Neurol. 2020 Sep;5(3):211-239. doi: 10.1136/svn-2020-000457. Epub 2020 Aug 21.

    PMID: 32826385BACKGROUND
  • Brenton JN, Lehner-Gulotta D, Woolbright E, Banwell B, Bergqvist AGC, Chen S, Coleman R, Conaway M, Goldman MD. Phase II study of ketogenic diets in relapsing multiple sclerosis: safety, tolerability and potential clinical benefits. J Neurol Neurosurg Psychiatry. 2022 Jun;93(6):637-644. doi: 10.1136/jnnp-2022-329074. Epub 2022 Apr 13.

    PMID: 35418509BACKGROUND
  • FOOD Trial Collaboration. Poor nutritional status on admission predicts poor outcomes after stroke: observational data from the FOOD trial. Stroke. 2003 Jun;34(6):1450-6. doi: 10.1161/01.STR.0000074037.49197.8C. Epub 2003 May 15.

    PMID: 12750536BACKGROUND
  • Mehta A, De Paola L, Pana TA, Carter B, Soiza RL, Kafri MW, Potter JF, Mamas MA, Myint PK. The relationship between nutritional status at the time of stroke on adverse outcomes: a systematic review and meta-analysis of prospective cohort studies. Nutr Rev. 2022 Nov 7;80(12):2275-2287. doi: 10.1093/nutrit/nuac034.

    PMID: 35640017BACKGROUND

Related Links

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

  • Junwei Hao, PhD

    Capital Medical University Xuanwu Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaoting Ma, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2024

First Posted

July 19, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 19, 2024

Record last verified: 2024-07