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Iron Long-Term Labelling Study Malawi

Sponsor
Prof. Michael B. Zimmermann (Other)
Overall Status
Unknown status
CT.gov ID
NCT02977806
Collaborator
(none)
48
Enrollment
1
Location
33.1
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    48 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Evaluation of Iron Metabolism Using a Novel Isotope Dilution Method in Malawian Children, Who Have Previously Participated in a Stable Isotope Study
    Actual Study Start Date :
    Mar 27, 2017
    Actual Primary Completion Date :
    Mar 15, 2019
    Anticipated Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. iron isotope composition in blood [2 years]

      the iron isotope ratio (tracer/tracee ratio) in blood should be analyzed with ICPMS every 120 days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 College of Medicine Blantyre Malawi 03

    Sponsors and Collaborators

    • Prof. Michael B. Zimmermann

    Investigators

    • Principal Investigator: Michael Zimmermann, Prof., Human Nutrition Laboratory, ETH Zürich

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Michael B. Zimmermann, Professor, Swiss Federal Institute of Technology
    ClinicalTrials.gov Identifier:
    NCT02977806
    Other Study ID Numbers:
    • Fe_LTL_Ma
    First Posted:
    Nov 30, 2016
    Last Update Posted:
    Apr 2, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Apr 2, 2019