An observational study in Iron Absorption, sponsored by Prof. Michael B. Zimmermann. Status unknown at 1 site in Malawi. Open to participants aged 3 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-02.
Sponsored by Prof. Michael B. Zimmermann · Observational
Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections in sub-Saharan Africa, a region with a high prevalence of iron deficiency, making the assessment of iron balance and efficiency of iron intervention difficult. A new method allowing accurate measurement of long-term oral iron absorption and allowing the estimation of iron requirements is highly needed. Such a novel method to quantify iron absorption and requirements using isotope dilution measurements in children should be validated in the present prospective observational study by following-up a group of 49 children given a stable iron isotope in an earlier trial. We will request seven blood samples within 2 years (sampling every four months) from the participants which will allow us to measure isotopic dilution for estimating total oral iron absorption over these 24 months.
Prof. Michael B. Zimmermann is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Malawian children who ingested stable iron isotopes in the frame of a former iron absorption study.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
iron isotope composition in blood
the iron isotope ratio (tracer/tracee ratio) in blood should be analyzed with ICPMS every 120 days
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Prof. Michael B. Zimmermann