A Study of Compound Amino Acid Capsule on Maintenance Hemodialysis Patients

Study Overview
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Brief Summary
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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: Can compound amino acid capsule improve the nutritional status of MHD patients? Can compound amino acid capsule help to correct the calcium and phosphorus metabolism imbalance of MHD patients? 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).

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

Conditions
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Hemodialysis Complication

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treatment group<br>MHD patients who took compound amino acid capsules regularly(2# tid po) for 9 months | |
| control group<br>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?
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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. |