Clinical trial NCT05874557: A Study of Compound Amino Acid Capsule on Maintenance Hemodialysis Patients
Official title: Effects of Compound Amino Acid Capsule on Nutrition, Calcium and Phosphorus Metabolism in Maintenance Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodialysis Complication
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: maintenance hemodialysis patients

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Serum Albumin at 3 months
timeFrame: Data of both groups at baseline and 3 months are collected and analyzed.
measure: Change from Baseline Serum Albumin at 6 months
timeFrame: Data of both groups at baseline and 6 months are collected and analyzed.
measure: Change from Baseline Serum Albumin at 9 months
timeFrame: Data of both groups at baseline and 9 months are collected and analyzed.
Secondary outcomes:
measure: Change from Baseline Prealbumin at 3 months of the treatment group
timeFrame: Data of the treatment group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline Prealbumin at 3 months of the control group
timeFrame: Data of the control group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline Prealbumin at 6 months of the treatment group
timeFrame: Data of the treatment group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline Prealbumin at 6 months of the control group
timeFrame: Data of the control group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline Prealbumin at 9 months of the treatment group
timeFrame: Data of the treatment group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline Prealbumin at 9 months of the control group
timeFrame: Data of the control group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline Hemoglobin at 3 months of the treatment group
timeFrame: Data of the treatment group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline Hemoglobin at 3 months of the control group
timeFrame: Data of the control group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline Hemoglobin at 6 months of the treatment group
timeFrame: Data of the treatment group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline Hemoglobin at 6 months of the control group
timeFrame: Data of the control group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline Hemoglobin at 9 months of the treatment group
timeFrame: Data of the treatment group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline Hemoglobin at 9 months of the control group
timeFrame: Data of the control group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline Ferritin at 3 months of the treatment group
timeFrame: Data of the treatment group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline Ferritin at 3 months of the control group
timeFrame: Data of the control group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline Ferritin at 6 months of the treatment group
timeFrame: Data of the treatment group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline Ferritin at 6 months of the control group
timeFrame: Data of the control group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline Ferritin at 9 months of the treatment group
timeFrame: Data of the treatment group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline Ferritin at 9 months of the control group
timeFrame: Data of the control group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline Calcium at 3 months of the treatment group
timeFrame: Data of the treatment group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline Calcium at 3 months of the control group
timeFrame: Data of the control group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline Calcium at 6 months of the treatment group
timeFrame: Data of the treatment group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline Calcium at 6 months of the control group
timeFrame: Data of the control group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline Calcium at 9 months of the treatment group
timeFrame: Data of the treatment group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline Calcium at 9 months of the control group
timeFrame: Data of the control group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline Phosphorus at 3 months of the treatment group
timeFrame: Data of the treatment group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline Phosphorus at 3 months of the control group
timeFrame: Data of the control group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline Phosphorus at 6 months of the treatment group
timeFrame: Data of the treatment group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline Phosphorus at 6 months of the control group
timeFrame: Data of the control group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline Phosphorus at 9 months of the treatment group
timeFrame: Data of the treatment group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline Phosphorus at 9 months of the control group
timeFrame: Data of the control group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline 1,25-(OH) 2-D3 at 3 months of the treatment group
timeFrame: Data of the treatment group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline 1,25-(OH) 2-D3 at 3 months of the control group
timeFrame: Data of the control group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline 1,25-(OH) 2-D3 at 6 months of the treatment group
timeFrame: Data of the treatment group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline 1,25-(OH) 2-D3 at 6 months of the control group
timeFrame: Data of the control group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline 1,25-(OH) 2-D3 at 9 months of the treatment group
timeFrame: Data of the treatment group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline 1,25-(OH) 2-D3 at 9 months of the control group
timeFrame: Data of the control group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline Intact Parathyroid Hormone (iPTH) at 3 months of the treatment group
timeFrame: Data of the treatment group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline iPTH at 3 months of the control group
timeFrame: Data of the control group at baseline and 3 months are collected and analyzed.
measure: Change from Baseline iPTH at 6 months of the treatment group
timeFrame: Data of the treatment group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline iPTH at 6 months of the control group
timeFrame: Data of the control group at baseline and 6 months are collected and analyzed.
measure: Change from Baseline iPTH at 9 months of the treatment group
timeFrame: Data of the treatment group at baseline and 9 months are collected and analyzed.
measure: Change from Baseline iPTH at 9 months of the control group
timeFrame: Data of the control group at baseline and 9 months are collected and analyzed.
Other outcomes:
measure: Adverse events (death in 9 months)
timeFrame: The mortality of both groups in the 9 observational months are collected.
measure: Adverse events (cardio-cerebrovascular accidents in 9 months)
timeFrame: The incidence of cardio-cerebrovascular accidents of both groups in the 9 observational months are collected.
measure: Adverse events (vascular access failure in 9 months）
timeFrame: The incidence of vascular access failure of both groups in the 9 observational months are collected.
measure: Drug Safety (liver function-ALT at 9 months)
timeFrame: Data of the both groups at 9 months are collected and analyzed.
measure: Drug Safety (liver function-AST at 9 months)
timeFrame: Data of the both groups at 9 months are collected and analyzed.
measure: Drug Safety (blood lipid-TG at 9 months)
timeFrame: Data of the both groups at 9 months are collected and analyzed.
measure: Drug Safety (blood lipid-TC at 9 months)
timeFrame: Data of the both groups at 9 months are collected and analyzed.
measure: Drug Safety (blood lipid-LDLC at 9 months)
timeFrame: Data of the both groups at 9 months are collected and analyzed.
measure: Drug Safety (blood glucose at 9 months)
timeFrame: Data of the both groups at 9 months are collected and analyzed.
Locations:
Study officials:
References: