NCT05366205

Brief Summary

This randomized controlled trial will focus on the effects of early oral nutritional supplementation on immune function in elderly patients with mild to moderate COVID-19 on maintenance hemodialysis. The purpose of this study is to determine whether early oral nutritional supplementation can improve immune function and clinical outcomes.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable covid19

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

April 30, 2022

Last Update Submit

May 6, 2022

Conditions

COVID-19Hemodiafiltration

Keywords

COVID-19Hemodiafiltrationimmune functionOral nutritional supplement

Outcome Measures

Primary Outcomes (3)

  • CD4 lymphocyte counts

    Baseline to discharge date, an average of 3 weeks

  • lymphocyte count

    Baseline to discharge date, an average of 3 weeks

  • T-lymphocyte subsets

    CD3+, CD4+, CD8+

    Baseline to discharge date, an average of 3 weeks

Secondary Outcomes (10)

  • Change in body weight

    Baseline to discharge date, an average of 3 weeks

  • change in white blood cell count

    Baseline to discharge date, an average of 3 weeks

  • change in hemoglobin

    Baseline to discharge date, an average of 3 weeks

  • change in albumin

    Baseline to discharge date, an average of 3 weeks

  • change in C-Reactive Protein

    Baseline to discharge date, an average of 3 weeks

  • +5 more secondary outcomes

Study Arms (2)

Oral nutritional supplements

EXPERIMENTAL

Patients in this arm will receive oral nutritional supplements 24-48 hours after admission，which is enteral nutrition emulsion(TPF-T).

Dietary Supplement: Oral nutritional supplement

nutrition consultation

SHAM COMPARATOR

Patients in this arm will receive nutrition consultation was given in addition to basic treatment.

Behavioral: Nutrition consultation

Interventions

Oral nutritional supplementDIETARY_SUPPLEMENT

Enteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days.

Oral nutritional supplements
Nutrition consultationBEHAVIORAL

Nutritional treatment advice will be given

nutrition consultation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60 and above;
  • Patients receiving hemodialysis with clinically confirmed end-stage renal disease
  • Positive diagnosis of COVID-19 by RT-PCR nasopharyngeal swab was classified as mild or moderate type
  • Patients who can eat on their own;
  • Patients had good compliance, fully understood the study content and signed informed consent.

You may not qualify if:

  • Contraindications of oral nutritional supplementation, such as intestinal obstruction and intestinal ischemia.
  • In an unstable state of vital signs such as shock.
  • In acute pancreatitis, cholecystitis acute attack period and 3 months after the last attack
  • Patients with moderate to severe cognitive impairment or mental diseases;
  • People who are allergic to intestinal nutrients
  • Refuse oral nutritional supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Yongmei Shi, MD

    Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Central Study Contacts

Yongmei Shi, MD

CONTACT

00862164370045shi.yongmei@163.com

Qianwen Jin, MD

CONTACT

008618701708006jqw12247@rjh.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

April 30, 2022

First Posted

May 9, 2022

Study Start

May 1, 2022

Primary Completion

July 31, 2022

Study Completion

August 31, 2022

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share