Clinical Trial

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

Active, Not Recruiting Phase 3
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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
Trial Details
NCT Number NCT07229456
Lead Sponsor Ain Shams University
Conditions Corrosive Injury
Enrollment 80 participants
Start Date 2024-10-01
Primary Completion 2025-10-31 (estimated)
Study Completion 2025-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-17