Iron Long-Term Labelling Study Malawi

The Evaluation of Iron Metabolism Using a Novel Isotope Dilution Method in Malawian Children, Who Have Previously Participated in a Stable Isotope Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02977806

Enrollment

Registered

2016-11-30

Start date

2017-03-27

Completion date

2019-12-31

Last updated

2019-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Absorption

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 10 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Countries

Malawi

Outcome results