Iron Long-Term Labelling Study Malawi

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-27

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Iron Absorption

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)

Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes