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

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.

Study Overview

• Status: Unknown
• Conditions: Iron Absorption

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi, 03
    • College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Malawian children who ingested stable iron isotopes in the frame of a former iron absorption study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prof. Michael B. Zimmermann
• Investigators: Principal Investigator: Michael Zimmermann, Prof., Human Nutrition Laboratory, ETH Zurich

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): March 15, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Fe_LTL_Ma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No