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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

November 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 4, 2025

Last Update Submitted That Met QC Criteria

July 3, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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