Iron Long-Term Labelling Study Malawi

Iron Absorption Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02977806
• Other study ID #: Fe_LTL_Ma
• Status: Active, not recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Iron Absorption

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