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Can a cheap iron syrup before surgery save kids from anemia risks?

NCT ID NCT05681871

Disease control Sponsor: University of Cape Town Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at whether giving children with iron-deficiency anemia oral iron for 6 to 12 weeks before elective surgery can raise their hemoglobin levels. Researchers enrolled 755 children in South Africa to test this simple, low-cost approach. The goal is to see if treating anemia before surgery improves outcomes and is practical in real-world clinics.

What this could mean

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

Active substance
oral iron (ferrous gluconate syrup or ferrous fumarate/folic acid tablets)
What this could lead to
If it works, this could show that a simple, low-cost oral iron treatment before surgery helps children recover better and reduces complications from anemia.
What could go wrong
This is a pilot study, so results are preliminary and may not apply to all children. Oral iron can cause stomach upset or constipation, and some children may not absorb it well.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

755 people

The number who actually took part.

Started

Feb 2023

Finished

May 2025

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

6 months to 16 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: * Age \> 6 months to \<16 years * Noncardiac surgery * Elective surgery * Anaemic as per World Health Organisation criteria Exclusion Criteria: * Patient or parent refusal * Unable to obtain written consent at the surgical outpatient clinic * Surgery planned within 4 weeks from surgical outpatient visit * Known history of acquired iron overload, family history of haemochromatosis or thalassemia * Known reason for anaemia (e.g., untreated vitamin B12 or folate deficiency or haemoglobinopathy) * Treatment with oral iron, erythropoietin, IV iron therapy or blood transfusion in the previous 12 weeks * Known hypersensitivity to oral iron or other contraindication to oral iron * Temperature \> 38.0 °C or receiving non-prophylactic antibiotics * Acute liver failure

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Conditions

The condition(s) this trial relates to.

anemia iron deficiency anemia

As listed by the trial registrant

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

Anaemia Interventional studies IRON Iron deficiency anemia Paediatric surgery Prospective studies

Contacts and locations

Locations

  • Red Cross War Memorial Children's Hospital

    Cape Town, Western Cape, 7700, South Africa

  • Tygerberg Hospital

    Cape Town, Western Cape, 7505, South Africa

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