A Study of Compound Amino Acid Capsule on Maintenance Hemodialysis Patients

Hemodialysis Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05874557
• Other study ID #: IIT-2023-0042
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: August 2023

Study information

• Verified date: May 2023
• Source: RenJi Hospital
• Contact: Renhua Lu, Doctor
• Phone: 86-13361958582
• Email: lurenhua1977[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Complication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.