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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02977806
Other study ID # Fe_LTL_Ma
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 27, 2017
Est. completion date December 31, 2019

Study information

Verified date April 2019
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date December 31, 2019
Est. primary completion date March 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Malawi College of Medicine Blantyre

Sponsors (1)

Lead Sponsor Collaborator
Prof. Michael B. Zimmermann

Country where clinical trial is conducted

Malawi, 

Outcome

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