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
1 other identifier
observational
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2016
CompletedFirst Posted
Study publicly available on registry
November 30, 2016
CompletedStudy Start
First participant enrolled
March 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedApril 2, 2019
April 1, 2019
2 years
November 28, 2016
April 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
iron isotope composition in blood
the iron isotope ratio (tracer/tracee ratio) in blood should be analyzed with ICPMS every 120 days
2 years
Eligibility Criteria
Malawian children who ingested stable iron isotopes in the frame of a former iron absorption study.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
College of Medicine
Blantyre, 03, Malawi
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Zimmermann, Prof.
Human Nutrition Laboratory, ETH Zürich
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 28, 2016
First Posted
November 30, 2016
Study Start
March 27, 2017
Primary Completion
March 15, 2019
Study Completion
December 31, 2019
Last Updated
April 2, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share