Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis Rats

July 3, 2025 updated by: Asmaa Abdel-mageed Muhammed, Aswan University Hospital

Effect of Lactoferrin Administration on Rhabdomyolysis-induced Heart and Kidney Injury in Rats

This study focuses on detecting the possible beneficial effect of Lactoferrin (Lf) administration on the kidney and the heart of glycerol-induced rhabdomyolysis (RM) in rats and its relation to ferroptosis and AMPK/Nrf2/ HO-1 signalling pathway. The main questions it aims to answer are:

  1. Is Lf administration 30 min. before or after RM induction in rats beneficial to kidneys and heart?
  2. When administered to glycerol-induced rats, does Lf act by upregulating the AMPK/Nrf2/ HO-1 signalling pathway and inhibiting ferroptosis?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
Interventional

Enrollment (Actual)

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.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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.

Study Locations

  • Egypt
      • Aswan, Egypt, 81528
        • Faculty of Medicine

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Twenty-four healthy male Wistar Albino rats weighing from 250 to 300 g

Exclusion Criteria:

  • No exclusion criteria as this study is used to detect effects of drugs on experimental rats.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control
Normal saline will be administered once to rats intramuscularly (10 mL/kg).
Diagnostic test: iron
Iron in kidney and heart tissues
Diagnostic test: MDA, TAC, and GSH
Oxidative stress levels in kidney and heart tissues
Other Names:
  • Malondialdehyde, Total antioxidant, and glutathione
Diagnostic test: Nrf2
Nrf2 expression in kidney and heart tissues
Other Names:
  • Nuclear factor erythroid 2-related factor 2
Diagnostic test: AMPK
AMPK levels in heart and kidney tissues
Other Names:
  • Adenosine monophosphate-activated protein kinase
Diagnostic test: HO-1
HO-1 levels in kidney and heart tissues
Other Names:
  • heme oxygenase-1
Active Comparator: RM
A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and normal saline (4ml/kg) will be administered by gavage.
Diagnostic test: iron
Iron in kidney and heart tissues
Diagnostic test: MDA, TAC, and GSH
Oxidative stress levels in kidney and heart tissues
Other Names:
  • Malondialdehyde, Total antioxidant, and glutathione
Diagnostic test: Nrf2
Nrf2 expression in kidney and heart tissues
Other Names:
  • Nuclear factor erythroid 2-related factor 2
Diagnostic test: AMPK
AMPK levels in heart and kidney tissues
Other Names:
  • Adenosine monophosphate-activated protein kinase
Diagnostic test: HO-1
HO-1 levels in kidney and heart tissues
Other Names:
  • heme oxygenase-1
Drug: glycerin
GLY intramuscular injection for rhabdomyolysis induction
Other Names:
  • GLY
Active Comparator: Lf-RM
A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. before RM induction
Diagnostic test: iron
Iron in kidney and heart tissues
Diagnostic test: MDA, TAC, and GSH
Oxidative stress levels in kidney and heart tissues
Other Names:
  • Malondialdehyde, Total antioxidant, and glutathione
Diagnostic test: Nrf2
Nrf2 expression in kidney and heart tissues
Other Names:
  • Nuclear factor erythroid 2-related factor 2
Diagnostic test: AMPK
AMPK levels in heart and kidney tissues
Other Names:
  • Adenosine monophosphate-activated protein kinase
Diagnostic test: HO-1
HO-1 levels in kidney and heart tissues
Other Names:
  • heme oxygenase-1
Drug: glycerin
GLY intramuscular injection for rhabdomyolysis induction
Other Names:
  • GLY
Drug: Lactoferrin
an iron-binding protein
Active Comparator: RM-Lf
A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. after RM induction.
Diagnostic test: iron
Iron in kidney and heart tissues
Diagnostic test: MDA, TAC, and GSH
Oxidative stress levels in kidney and heart tissues
Other Names:
  • Malondialdehyde, Total antioxidant, and glutathione
Diagnostic test: Nrf2
Nrf2 expression in kidney and heart tissues
Other Names:
  • Nuclear factor erythroid 2-related factor 2
Diagnostic test: AMPK
AMPK levels in heart and kidney tissues
Other Names:
  • Adenosine monophosphate-activated protein kinase
Diagnostic test: HO-1
HO-1 levels in kidney and heart tissues
Other Names:
  • heme oxygenase-1
Drug: glycerin
GLY intramuscular injection for rhabdomyolysis induction
Other Names:
  • GLY
Drug: Lactoferrin
an iron-binding protein

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
Nrf2 expression
Time Frame: 2 months
Nrf2 expression in heart and kidney tissues
2 months
AMPK levels
Time Frame: 2 months
AMPK levels in kidney and heart tissue homogenate
2 months
HO-1 levels
Time Frame: 2 months
HO-1 levels in kidney and heart tissue homogenate
2 months

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
iron levels
Time Frame: 2 months
Iron levels in heart and kidney tissue homogenate
2 months
MDA levels
Time Frame: 2 months
MDA levels in heart and kidney tissue homogenate
2 months
TAC levels
Time Frame: 2 months
TAC levels in heart and kidney tissue homogenate
2 months
GSH levels
Time Frame: 2 months
GSH levels in heart and kidney tissue homogenate
2 months

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.
Aswan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

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.
November 1, 2024

Primary Completion (Actual)

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.
March 1, 2025

Study Completion (Actual)

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.
April 1, 2025

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).
July 1, 2024

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.
July 1, 2024

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.
July 9, 2024

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.
July 4, 2025

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.
July 3, 2025

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.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • Lactoferrin in rhabdomyolysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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