Evaluation of the Role of N Acetyl Cysteine and Vitamin D in Improving Outcomes After Corrosive Ingestion

Summary

The goal of this clinical trial is to learn if N acetyl cysteine and vitaminD work to improve outcomes after corrosive ingestion in children.

The main questions it aims to answer are:

Does N acetyl cysteine and vitamin D decrease incidence of strictures after corrosive ingestion in children.

Researchers will compare the effect of N acetyl cysteine and vitamin D in decreasing complication , length of hospital stay and start of complete oral intake Eighty patients were randomly assigned into four groups (1 control and 3 intervention groups 20 patients each)

Group 1 (Control group):

o Patients allocated in this group received the standard treatment protocol only according to PCC-ASUH guidelines

Group 2 (NAC group):

o Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to NAC with loading dose of 150 mg/kg diluted in 200 ml dextrose 5% or saline over 1 hour, followed by a maintenance dose of 50 mg/kg diluted in 500 ml of dextrose 5% or saline over 4 hours then followed by 100 ml/kg diluted in 1000 ml of dextrose 5% or saline over 16 hours

Group 3 (Vitamin D group):

Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to vitamin D in a single intramuscular high-dose (300,000 IU) which was given to all patients regardless patient's age

Group 4 (NAC+Vitamin D group):

Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to both vitamin D and NAC, in the same doses as groups (2 and 3

Conditions

• Corrosive Injury

Interventions

DRUG

N Acetyl Cysteine

N-acetyl cysteine (NAC) has a well-established safety profile, its remarkable antioxidant and anti-inflammatory capacity is the biochemical basis used to treat several diseases related to oxidative stress and inflammation. The primary role of NAC as an antioxidant stems from its ability to increase the intracellular concentration of glutathione (GSH), which is responsible for cellular redox imbalance . It is assumed that NAC acts as a reductant of disulfide bonds, a scavenger of reactive oxygen species and/or a precursor for glutathione biosynthesis N-acetyl cysteine was observed to be useful in the treatment of esophageal damage associated with corrosive substances and in achieving histopathological improvement in an experimental setting

DRUG

Vitamin D (Cholecalciferol )

counteracts the pro-fibrotic signals, such as transforming growth factor-β1 (TGF-β1), through several biochemical mechanisms. This inhibits myofibroblasts activation and extra cellular matrix deposition. In addition, vitamin D reduces the expression of pro-fibrotic target genes The antioxidant effect of vitamin D is between the newest suggested non-calcemic roles of this compound through inducing the expression of several molecules involved in the antioxidant defense system including glutathione, glutathione peroxidase and superoxide dismutase (SOD) and suppressing the expression of NADPH oxidase

DRUG

control group

Patients allocated in this group received the standard treatment protocol only according to PCC-ASUH guidelines.

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Principal Investigators

• Eglal H Elawady, Professor of toxicology · faculty of medicine - Ain Shams University

• Walaa G Abdelhamid, Assistant Professor · faculty of medicine - Ain Shams University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2025-10-31

Completion

2025-12-01

Countries

• Egypt

Study Locations