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Completed

NCT Number: NCT06491394

Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis 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?

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Key information

Conditions

Rhabdomyolysis Muscular Diseases Musculoskeletal Diseases

Age range

10 week–12 week

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine

Aswān, Aswan Governorate, 81528, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactoferrin

Drug

an iron-binding protein

iron

Diagnostic Test

Iron in kidney and heart tissues

MDA, TAC, and GSH

Diagnostic Test

Oxidative stress levels in kidney and heart tissues

Other names: Malondialdehyde, Total antioxidant, and glutathione

Nrf2

Diagnostic Test

Nrf2 expression in kidney and heart tissues

Other names: Nuclear factor erythroid 2-related factor 2

AMPK

Diagnostic Test

AMPK levels in heart and kidney tissues

Other names: Adenosine monophosphate-activated protein kinase

HO-1

Diagnostic Test

HO-1 levels in kidney and heart tissues

Other names: heme oxygenase-1

glycerin

Drug

GLY intramuscular injection for rhabdomyolysis induction

Other names: GLY

Primary outcomes

  1. Nrf2 expression

    Time frame: 2 months

    Nrf2 expression in heart and kidney tissues

  2. AMPK levels

    Time frame: 2 months

    AMPK levels in kidney and heart tissue homogenate

  3. HO-1 levels

    Time frame: 2 months

    HO-1 levels in kidney and heart tissue homogenate

Secondary outcomes

  1. iron levels

    Time frame: 2 months

    Iron levels in heart and kidney tissue homogenate

  2. MDA levels

    Time frame: 2 months

    MDA levels in heart and kidney tissue homogenate

  3. TAC levels

    Time frame: 2 months

    TAC levels in heart and kidney tissue homogenate

  4. GSH levels

    Time frame: 2 months

    GSH levels in heart and kidney tissue homogenate

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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