CompletedNot Applicable

Iron and Vitamin A in School Children

Ethiopia504 participantsStarted 2020-11-02

Plain-language summary

The WHO recommended intermittent iron supplementation as a strategy for prevention of anemia and iron deficiency among school age children. Several aspects of cognitive development, co-supplementation with other micronutrients, severe adverse events especially in the context of malaria were missing. The investigators will evaluate the effectiveness of intermittent iron and vitamin A supplementation on cognitive development and anemia and iron status of Rural Ethiopian school children.

Who can participate

Age range

7 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * One or both their parents signed informed consent form; * Their parents planned to stay during the period of the study (for the full academic year) in the kebele; and * They accept of the intervention package including blood draw and home visits. School children with severe anemia (Hb concentration \<80 g/L) will be treated by conventional protocol for three months at nearby health centres. After reassessing their haemoglobin concentrations, they can be assigned to their intervention groups if they become eligible as described above. Exclusion Criteria: * Chronically ill children like diagnosed diabetic and asthma * Severely under nourished children (defined as body mass index z-score \<-3 standard deviations of the median WHO reference population) * Those who are treated for tuberculosis or suspected to have tuberculosis * Children with diagnosed haemoglobinopathy (sickle cell and thalassemias) * Children with night blindness

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Memory span

Timeframe: Memory span of the children will be assessed at 9 months

Spatial exploration and awareness

Timeframe: Spatial exploration and awareness of the children will be assessed at 9 months

Reasoning ability

Timeframe: The reasoning ability of the children will be assessed at 9 months

Anemia

Timeframe: Hemoglobin concentrations of children will be assessed at 9 months

Plasma ferritin

Timeframe: Plasma ferritin is assessed in all children at 9 months

Soluble transferrin receptor

Timeframe: Soluble transferrin receptor is assessed in all children at 9 months

Trial details

NCT IDNCT04137354

SponsorUniversity Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-28

View on ClinicalTrials.gov More Anemia, Iron Deficiency trials