Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis Rats

Aswan University Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Rhabdomyolysis

Treatments: Diagnostic Test: Nrf2; Drug: glycerin; Diagnostic Test: MDA, TAC, and GSH; Diagnostic Test: iron; Drug: Lactoferrin; Diagnostic Test: HO-1; Diagnostic Test: AMPK

Study type: Interventional

Funder types: Other

Identifiers

NCT06491394

Lactoferrin in rhabdomyolysis

Details and patient eligibility

About

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?

Enrollment: 24 estimated patients

Sex: Male

Ages: 10 to 12 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 4 patient groups

Control

Sham Comparator group

Description:

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

Treatment:

Diagnostic Test: AMPK

Diagnostic Test: HO-1

Diagnostic Test: MDA, TAC, and GSH

Diagnostic Test: iron

Diagnostic Test: Nrf2

RM

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: AMPK

Diagnostic Test: HO-1

Drug: glycerin

Diagnostic Test: MDA, TAC, and GSH

Diagnostic Test: iron

Diagnostic Test: Nrf2

Lf-RM

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: AMPK

Diagnostic Test: HO-1

Drug: Lactoferrin

Drug: glycerin

Diagnostic Test: MDA, TAC, and GSH

Diagnostic Test: iron

Diagnostic Test: Nrf2

RM-Lf

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: AMPK

Diagnostic Test: HO-1

Drug: Lactoferrin

Drug: glycerin

Diagnostic Test: MDA, TAC, and GSH

Diagnostic Test: iron

Diagnostic Test: Nrf2