A Study of Compound Amino Acid Capsule on Maintenance Hemodialysis Patients

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
• Conditions: Hemodialysis Complication

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Renhua Lu, Doctor; Phone Number: 86-13361958582; Email: [email protected]

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)	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)	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）	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)	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)	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)	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)	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)	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)	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

• Sponsor: RenJi Hospital

Study record dates

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