A Study of Compound Amino Acid Capsule on Maintenance Hemodialysis Patients

May 15, 2023 updated by: RenJi Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Serum Albumin at 3 months
Time Frame: Data of both groups at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of both groups at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of both groups at baseline and 9 months are collected and analyzed.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Prealbumin at 3 months of the treatment group
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 3 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 6 months are collected and analyzed.
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
Time Frame: Data of the treatment group at baseline and 9 months are collected and analyzed.
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
Time Frame: Data of the control group at baseline and 9 months are collected and analyzed.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events (death in 9 months)
Time Frame: The mortality of both groups in the 9 observational months are collected.
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)
Time Frame: The incidence of cardio-cerebrovascular accidents of both groups in the 9 observational months are collected.
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）
Time Frame: The incidence of vascular access failure of both groups in the 9 observational months are collected.
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)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
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)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
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)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
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)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
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)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
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)
Time Frame: Data of the both groups at 9 months are collected and analyzed.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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