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Can common supplements prevent serious gut damage after poisoning?

NCT ID NCT07229456

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether N-acetyl cysteine (NAC) and vitamin D, given alongside standard care, can reduce the risk of esophageal or stomach strictures (scarring that narrows the passage) in children who have swallowed a corrosive substance. Eighty children aged 0–18 with moderate to severe symptoms are randomly assigned to one of four groups: standard care alone, standard care plus NAC, standard care plus a high-dose vitamin D injection, or standard care plus both NAC and vitamin D. The main goal is to see if these supplements lower the rate of stricture formation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
N-acetyl cysteine and vitamin D
What this could lead to
If it works, this could offer a simple, safe way to prevent serious scarring in the esophagus or stomach after swallowing a corrosive substance.
What could go wrong
This is a small, single-center trial with only 80 children. The results may not apply to everyone, and the supplements might not reduce stricture risk as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

80 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ain Shams University

    Cairo, Egypt