A Study of Compound Amino Acid Capsule on Maintenance Hemodialysis Patients

May 15, 2023 updated by: RenJi Hospital

Effects of Compound Amino Acid Capsule on Nutrition, Calcium and Phosphorus Metabolism in Maintenance Hemodialysis Patients

The goal of this retrospective cohort study is to investigate the effects of compound amino acid capsule on nutrition, calcium and phosphorus metabolism in maintenance hemodialysis(MHD) patients. The main questions it aims to answer are:

  1. Can compound amino acid capsule improve the nutritional status of MHD patients?
  2. Can compound amino acid capsule help to correct the calcium and phosphorus metabolism imbalance of MHD patients?
  3. Is compound amino acid capsule safe for MHD patients? We will collect the medical history and laboratory data of MHD patients who regularly took compound amino acid capsule for 9 months or did not use the same preparation in previous medical experience. We focus on the difference of serum albumin level between the treatment group and the control group within 9 months, as well as prealbumin, hemoglobin, ferritin, calcium, phosphorus, 1,25-OH 2-D3 and intact parathyroid hormone (iPTH).

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

maintenance hemodialysis patients

Description

Inclusion Criteria:

  • Patients who received maintenance hemodialysis (≥ 3 months) in Renji Hospital;
  • Regularly participate in the routine laboratory examination of the hemodialysis center every 3 months;
  • Inclusion criteria of the treatment group: regular treatment with compound amino acid capsule for 9 months (2 tablets, 3 times a day, orally);
  • Inclusion criteria of the control group: no compound amino acid capsules or similar nutritional supplement were taken.

Exclusion Criteria:

  • Severe heart failure (NYHA III/IV);
  • Human immunodeficiency virus positive or is suffering from other serious infectious diseases;
  • Have a history of malignant tumor;
  • Women during pregnancy or lactation;
  • Exclusion criteria for treatment group: previous use of amino acids or compound ketoacid supplement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
treatment group
MHD patients who took compound amino acid capsules regularly(2# tid po) for 9 months
control group
MHD patients in the control group are selected by PSM with age, sex, dialysis month, baseline BMI, baseline Kt/V and baseline ultrafiltration volume. And they did not take compound amino acid capsules or similar amino acid nutritional supplement for the same 9 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Serum Albumin at 3 months
Time Frame: Data of both groups at baseline and 3 months are collected and analyzed.
Change from baseline serum albumin at 3 months of the treatment group and control group are compared.
Data of both groups at baseline and 3 months are collected and analyzed.
Change from Baseline Serum Albumin at 6 months
Time Frame: Data of both groups at baseline and 6 months are collected and analyzed.
Change from baseline serum albumin at 6 months of the treatment group and control group are compared.
Data of both groups at baseline and 6 months are collected and analyzed.
Change from Baseline Serum Albumin at 9 months
Time Frame: Data of both groups at baseline and 9 months are collected and analyzed.
Change from baseline serum albumin at 9 months of the treatment group and control group are compared.
Data of both groups at baseline and 9 months are collected and analyzed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Prealbumin at 3 months of the treatment group
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Within the treatment group, prealbumin at 3 months is compared to baseline. In other words, change from baseline prealbumin at 3 months is compared to 0.
Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Prealbumin at 3 months of the control group
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
Within the control group, prealbumin at 3 months is compared to baseline. In other words, change from baseline prealbumin at 3 months is compared to 0.
Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Prealbumin at 6 months of the treatment group
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Within the treatment group, prealbumin at 6 months is compared to baseline. In other words, change from baseline prealbumin at 6 months is compared to 0.
Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Prealbumin at 6 months of the control group
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
Within the control group, prealbumin at 6 months is compared to baseline. In other words, change from baseline prealbumin at 6 months is compared to 0.
Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Prealbumin at 9 months of the treatment group
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Within the treatment group, prealbumin at 9 months is compared to baseline. In other words, change from baseline prealbumin at 9 months is compared to 0.
Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Prealbumin at 9 months of the control group
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
Within the control group, prealbumin at 9 months is compared to baseline. In other words, change from baseline prealbumin at 9 months is compared to 0.
Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Hemoglobin at 3 months of the treatment group
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Within the treatment group, hemoglobin at 3 months is compared to baseline. In other words, change from baseline hemoglobin at 3 months is compared to 0.
Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Hemoglobin at 3 months of the control group
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
Within the control group, hemoglobin at 3 months is compared to baseline. In other words, change from baseline hemoglobin at 3 months compared to 0.
Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Hemoglobin at 6 months of the treatment group
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Within the treatment group, hemoglobin at 6 months is compared to baseline. In other words, change from baseline hemoglobin at 6 months is compared to 0.
Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Hemoglobin at 6 months of the control group
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
Within the control group, hemoglobin at 6 months is compared to baseline. In other words, change from baseline hemoglobin at 6 months is compared to 0.
Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Hemoglobin at 9 months of the treatment group
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Within the treatment group, hemoglobin at 9 months is compared to baseline. In other words, change from baseline hemoglobin at 9 months is compared to 0.
Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Hemoglobin at 9 months of the control group
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
Within the control group, hemoglobin at 9 months is compared to baseline. In other words, change from baseline hemoglobin at 9 months is compared to 0.
Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Ferritin at 3 months of the treatment group
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Within the treatment group, ferritin at 3 months is compared to baseline. In other words, change from baseline ferritin at 3 months is compared to 0.
Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Ferritin at 3 months of the control group
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
Within the control group, ferritin at 3 months is compared to baseline. In other words, change from baseline ferritin at 3 months is compared to 0.
Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Ferritin at 6 months of the treatment group
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Within the treatment group, ferritin at 6 months is compared to baseline. In other words, change from baseline ferritin at 6 months is compared to 0.
Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Ferritin at 6 months of the control group
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
Within the control group, ferritin at 6 months is compared to baseline. In other words, change from baseline ferritin at 6 months is compared to 0.
Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Ferritin at 9 months of the treatment group
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Within the treatment group, ferritin at 9 months is compared to baseline. In other words, change from baseline ferritin at 9 months is compared to 0.
Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Ferritin at 9 months of the control group
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
Within the control group, ferritin at 9 months is compared to baseline. In other words, change from baseline ferritin at 9 months is compared to 0.
Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Calcium at 3 months of the treatment group
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Within the treatment group, calcium at 3 months is compared to baseline. In other words, change from baseline calcium at 3 months is compared to 0.
Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Calcium at 3 months of the control group
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
Within the control group, calcium at 3 months is compared to baseline. In other words, change from baseline calcium at 3 months is compared to 0.
Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Calcium at 6 months of the treatment group
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Within the treatment group, calcium at 6 months is compared to baseline. In other words, change from baseline calcium at 6 months is compared to 0.
Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Calcium at 6 months of the control group
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
Within the control group, calcium at 6 months is compared to baseline. In other words, change from baseline calcium at 6 months is compared to 0.
Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Calcium at 9 months of the treatment group
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Within the treatment group, calcium at 9 months is compared to baseline. In other words, change from baseline calcium at 9 months is compared to 0.
Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Calcium at 9 months of the control group
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
Within the control group, calcium at 9 months is compared to baseline. In other words, change from baseline calcium at 9 months is compared to 0.
Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Phosphorus at 3 months of the treatment group
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Within the treatment group, phosphorus at 3 months is compared to baseline. In other words, change from baseline phosphorus at 3 months is compared to 0.
Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline Phosphorus at 3 months of the control group
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
Within the control group, phosphorus at 3 months is compared to baseline. In other words, change from baseline phosphorus at 3 months is compared to 0.
Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline Phosphorus at 6 months of the treatment group
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Within the treatment group, phosphorus at 6 months is compared to baseline. In other words, change from baseline phosphorus at 6 months is compared to 0.
Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline Phosphorus at 6 months of the control group
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
Within the control group, phosphorus at 6 months is compared to baseline. In other words, change from baseline phosphorus at 6 months is compared to 0.
Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline Phosphorus at 9 months of the treatment group
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Within the treatment group, phosphorus at 9 months is compared to baseline. In other words, change from baseline phosphorus at 9 months is compared to 0.
Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline Phosphorus at 9 months of the control group
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
Within the control group, phosphorus at 9 months is compared to baseline. In other words, change from baseline phosphorus at 9th month is compared to 0.
Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 3 months of the treatment group
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Within the treatment group, 1,25-(OH) 2-D3 at 3 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 3 months is compared to 0.
Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 3 months of the control group
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
Within the control group, 1,25-(OH) 2-D3 at 3 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 3 months is compared to 0.
Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 6 months of the treatment group
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Within the treatment group, 1,25-(OH) 2-D3 at 6 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 6 months is compared to 0.
Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 6 months of the control group
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
Within the control group, 1,25-(OH) 2-D3 at 6 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 6 months is compared to 0.
Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 9 months of the treatment group
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Within the treatment group, 1,25-(OH) 2-D3 at 9 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 9 months is compared to 0.
Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline 1,25-(OH) 2-D3 at 9 months of the control group
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
Within the control group, 1,25-(OH) 2-D3 at 9 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 9 months is compared to 0.
Data of the control group at baseline and 9 months are collected and analyzed.
Change from Baseline Intact Parathyroid Hormone (iPTH) at 3 months of the treatment group
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
Within the treatment group, iPTH at 3 months is compared to baseline. In other words, change from baseline iPTH at 3 months is compared to 0.
Data of the treatment group at baseline and 3 months are collected and analyzed.
Change from Baseline iPTH at 3 months of the control group
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
Within the control group, iPTH at 3 months is compared to baseline. In other words, change from baseline iPTH at 3 months is compared to 0.
Data of the control group at baseline and 3 months are collected and analyzed.
Change from Baseline iPTH at 6 months of the treatment group
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
Within the treatment group, iPTH at 6 months is compared to baseline. In other words, change from baseline iPTH at 6 months is compared to 0.
Data of the treatment group at baseline and 6 months are collected and analyzed.
Change from Baseline iPTH at 6 months of the control group
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
Within the control group, iPTH at 6 months is compared to baseline. In other words, change from baseline iPTH at 6 months is compared to 0.
Data of the control group at baseline and 6 months are collected and analyzed.
Change from Baseline iPTH at 9 months of the treatment group
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
Within the treatment group, iPTH at 9 months is compared to baseline. In other words, change from baseline iPTH at 9 months is compared to 0.
Data of the treatment group at baseline and 9 months are collected and analyzed.
Change from Baseline iPTH at 9 months of the control group
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
Within the control group, iPTH at 9 months is compared to baseline. In other words, change from baseline iPTH at 9 months is compared to 0.
Data of the control group at baseline and 9 months are collected and analyzed.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (death in 9 months)
Time Frame: The mortality of both groups in the 9 observational months are collected.
The mortality is compared between the treatment group and the control group within 9 months.
The mortality of both groups in the 9 observational months are collected.
Adverse events (cardio-cerebrovascular accidents in 9 months)
Time Frame: The incidence of cardio-cerebrovascular accidents of both groups in the 9 observational months are collected.
The incidence of cardio-cerebrovascular accidents is compared between the treatment group and the control group within 9 months.
The incidence of cardio-cerebrovascular accidents of both groups in the 9 observational months are collected.
Adverse events (vascular access failure in 9 months)
Time Frame: The incidence of vascular access failure of both groups in the 9 observational months are collected.
The incidence of vascular access failure is compared between the treatment group and the control group within 9 months.
The incidence of vascular access failure of both groups in the 9 observational months are collected.
Drug Safety (liver function-ALT at 9 months)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
The alanine transaminase(ALT) level at 9 months is compared between the treatment group and the control group.
Data of the both groups at 9 months are collected and analyzed.
Drug Safety (liver function-AST at 9 months)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
The aspartate transaminase(AST) level at 9 months is compared between the treatment group and the control group.
Data of the both groups at 9 months are collected and analyzed.
Drug Safety (blood lipid-TG at 9 months)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
The triglyceride (TG) level at 9 months is compared between the treatment group and the control group.
Data of the both groups at 9 months are collected and analyzed.
Drug Safety (blood lipid-TC at 9 months)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
The total cholesterol (TC) level at 9 months is compared between the treatment group and the control group.
Data of the both groups at 9 months are collected and analyzed.
Drug Safety (blood lipid-LDLC at 9 months)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
The low density lipoprotein cholesterol (LDLC) level at 9 months is compared between the treatment group and the control group.
Data of the both groups at 9 months are collected and analyzed.
Drug Safety (blood glucose at 9 months)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
The random blood glucose level at 9 months is compared between the treatment group and the control group.
Data of the both groups at 9 months are collected and analyzed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

August 1, 2023

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IIT-2023-0042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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