A Study of Compound Amino Acid Capsule on Maintenance Hemodialysis Patients

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Hemodialysis Complication

Study type: Observational

Funder types: Other

Identifiers

NCT05874557

IIT-2023-0042

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

treatment group

Description:

MHD patients who took compound amino acid capsules regularly(2# tid po) for 9 months

control group

Description:

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.