Iron Long-Term Labelling Study Malawi

• Conditions: Iron Absorption

• Registration Number: NCT02977806
• Lead Sponsor: Prof. Michael B. Zimmermann

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-30
• Study Start: 2017-03-27
• Primary Completion: 2019-03-15
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-02
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Have participated in the original absorption study and the two follow-up samplings
• Signed written informed consent from the guardian to participate in the study

Exclusion Criteria

• Long-term medication
• Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the guardian's statement or med-ical examination (health booklet))
• Blood losses (surgery, accident) or blood transfusion during the past 4 months before study start.
• Residence too far away (> 2 hours by motorbike) from study location (Zomba)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
iron isotope composition in blood	2 years	the iron isotope ratio (tracer/tracee ratio) in blood should be analyzed with ICPMS every 120 days

Trial Locations

Locations (1)

College of Medicine; 🇲🇼 Blantyre, Malawi