NCT06491394

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 1, 2024

Last Update Submit

July 3, 2025

Conditions

Rhabdomyolysis

Outcome Measures

Primary Outcomes (3)

  • Nrf2 expression

    Nrf2 expression in heart and kidney tissues

    2 months

  • AMPK levels

    AMPK levels in kidney and heart tissue homogenate

    2 months

  • HO-1 levels

    HO-1 levels in kidney and heart tissue homogenate

    2 months

Secondary Outcomes (4)

  • iron levels

    2 months

  • MDA levels

    2 months

  • TAC levels

    2 months

  • GSH levels

    2 months

Study Arms (4)

Control

SHAM COMPARATOR

Normal saline will be administered once to rats intramuscularly (10 mL/kg).

Diagnostic Test: ironDiagnostic Test: MDA, TAC, and GSHDiagnostic Test: Nrf2Diagnostic Test: AMPKDiagnostic Test: HO-1

RM

ACTIVE COMPARATOR

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: ironDiagnostic Test: MDA, TAC, and GSHDiagnostic Test: Nrf2Diagnostic Test: AMPKDiagnostic Test: HO-1Drug: glycerin

Lf-RM

ACTIVE COMPARATOR

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

Drug: LactoferrinDiagnostic Test: ironDiagnostic Test: MDA, TAC, and GSHDiagnostic Test: Nrf2Diagnostic Test: AMPKDiagnostic Test: HO-1Drug: glycerin

RM-Lf

ACTIVE COMPARATOR

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.

Drug: LactoferrinDiagnostic Test: ironDiagnostic Test: MDA, TAC, and GSHDiagnostic Test: Nrf2Diagnostic Test: AMPKDiagnostic Test: HO-1Drug: glycerin

Interventions

LactoferrinDRUG

an iron-binding protein

Lf-RMRM-Lf
ironDIAGNOSTIC_TEST

Iron in kidney and heart tissues

ControlLf-RMRMRM-Lf
MDA, TAC, and GSHDIAGNOSTIC_TEST

Oxidative stress levels in kidney and heart tissues

Also known as: Malondialdehyde, Total antioxidant, and glutathione
ControlLf-RMRMRM-Lf
Nrf2DIAGNOSTIC_TEST

Nrf2 expression in kidney and heart tissues

Also known as: Nuclear factor erythroid 2-related factor 2
ControlLf-RMRMRM-Lf
AMPKDIAGNOSTIC_TEST

AMPK levels in heart and kidney tissues

Also known as: Adenosine monophosphate-activated protein kinase
ControlLf-RMRMRM-Lf
HO-1DIAGNOSTIC_TEST

HO-1 levels in kidney and heart tissues

Also known as: heme oxygenase-1
ControlLf-RMRMRM-Lf
glycerinDRUG

GLY intramuscular injection for rhabdomyolysis induction

Also known as: GLY
Lf-RMRMRM-Lf

Eligibility Criteria

Age10 Weeks - 12 Weeks
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Aswān, Aswan Governorate, 81528, Egypt

Location

Related Links

MeSH Terms

Conditions

Rhabdomyolysis

Interventions

LactoferrinGlycerol

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesGlycoproteinsGlycoconjugatesCarbohydratesTransferrinsIron-Binding ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsLactoglobulinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsGlobulinsMetalloproteinsTriose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

November 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

July 4, 2025

Record last verified: 2025-07

Locations

EG(1)