Comparison of Iron Absorption From Extruded FePP-fortified Rice Containing Zinc, Citric Acid/Tris… (NCT02714075) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Iron Absorption From Extruded FePP-fortified Rice Containing Zinc, Citric Acid/Trisodium Citrate and EDTA
Ghana, Switzerland30 participantsStarted 2016-04
Plain-language summary
Rice can only be fortified with ferric pyrophosphate (FePP), which is of low bioavailability in human subjects. Compounds such as citric acid/trisodium citrate (CA/TSC) or sodium ethylene-diamine tetraacetic-acid (EDTA) could serve as absorption enhancers. Recent findings from single meal studies indicate CA/TSC to have an enhancing effect on iron absorption from FePP-fortified rice. In contrast, ZnO has been suggested to have detrimental effects. Furthermore, in vitro findings suggest an increased iron solubility from iron and EDTA-co-fortified rice - but the bioavailability in humans remains to be investigated. These effects should thus be investigated in 'real-life' conditions, when fortified rice is implemented in a complete diet administered throughout several days in a target population for a rice fortification program.
Objective: To assess iron absorption from the diet from different iron fortified rice formulations in iron deficient anaemic children.
The investigators aim to conduct an iron absorption study in 30 Ghanaian school-age children investigating different fortification approaches in a multiple meal randomized, cross over study.
Who can participate
Age range
5 Years – 9 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:
* Iron deficient and/or anemic as per definition;
* Read and signed informed consent form by the caregiver (or has been read out to the caregiver in case of illiteracy);
* Absence of any metabolic-, gastrointestinal or chronic diseases.
Exclusion Criteria:
* Severe underweight (Z-score weight-for-age \<-3);
* Severe wasting (Z-score weight-for-height\<-3);
* Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol;
* Participants taking part in other studies requiring the drawing of blood;
* Participants who will not be able to comply with the protocol (e.g. plan to move, planned absence, etc.);
* Regular intake (\>2 days) of iron-containing mineral and vitamin supplements within the last 2 months.
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.