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

NCT07229456 | Active Not Recruiting Phase 3

• 1 other identifier: FAMSU MS 611/2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

corrosive ingestion; vitamin D; N acetyl cysteine

Outcome Measures

Primary Outcomes (1)

• Stricture formation

  Stenosis of esophygeal lumen or gastric lumen after corrosive ingestion which will be seen in barium swallow and meal

  21 days after corrosive ingestion

Study Arms (4)

control

ACTIVE COMPARATOR

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

Drug: control group

N acetyl cysteine group

ACTIVE COMPARATOR

* 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 * Preparation and administration of NAC were adjusted according to the age of the patient. In those \>12 years old, total volume (NAC and IV fluid) for the bolus, 4-hour infusion, and 16 hours infusion was 200 ml, 500 ml, and 1 liter, respectively. In children \<12 years but over 20 kg, volumes were 100 ml, 250 ml, and 500 ml respectively. In those under 20 kg volumes were 3 ml/kg, 7 ml/kg, and 14 ml/kg respectively

Drug: N Acetyl Cysteine; Drug: control group

vitamin D group

ACTIVE COMPARATOR

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

Drug: Vitamin D (Cholecalciferol ); Drug: control group

N acetyl cysteine and Vitamin D group

ACTIVE COMPARATOR

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).

Drug: N Acetyl Cysteine; Drug: Vitamin D (Cholecalciferol ); Drug: control group

Interventions

N Acetyl Cysteine DRUG

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

Also known as: Acetyle cysteine, Hidonac

N acetyl cysteine and Vitamin D group; N acetyl cysteine group

Vitamin D (Cholecalciferol ) DRUG

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

Also known as: (Cholecalciferol ), osavidin

N acetyl cysteine and Vitamin D group; vitamin D group

control group DRUG

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

N acetyl cysteine and Vitamin D group; N acetyl cysteine group; control; vitamin D group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The study included all patients aged from 0 to 18 years old, of both sex, admitted to the PCC-ASUH with confirmed history of corrosive ingestion and exhibiting moderate or severe symptoms (as determined by Poisoning Severity Score 2 or 3, respectively) and DROOL score (Drooling, Reluctance, Oropharynx, Others, and leukocytosis) ≤ 6

You may not qualify if:

• o Asymptomatic patients.
• Patients exposed to corrosives through routes other than ingestion (e.g., inhalation, dermal or eye contact).
• Patients with a delay time of more than 24 h.
• Patients who co-ingested other poisons.
• Patients presented with GIT perforation after corrosive ingestion.
• Patients who received treatment before admission.
• Patients receiving chemotherapy or radiation.
• Patients with known blood disorders or malignancy.
• Patients with history of blood transfusion in the last 90 days.
• Patients with recent infections in the last 14 day

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Acetylcysteine; Cholecalciferol; Control Groups

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Eglal H Elawady, Professor of toxicology

  faculty of medicine - Ain Shams University

  STUDY CHAIR

• Walaa G Abdelhamid, Assistant Professor

  faculty of medicine - Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eighty patients were randomly assigned into four groups (1 control and 3 intervention groups 20 patients each)

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: November 17, 2025
• Study Start: October 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)