Iron Long-Term Labelling Study Benin

Iron Absorption Clinical Trial

Official title:

The Evaluation of Iron Supplementation and Iron Requirements Using a Novel Isotope Dilution Method in Beninese Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02979080
• Other study ID #: Fe_LTL_Be
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 10, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: October 2018
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 potential reference method to quantify iron absorption and requirements using isotope dilution measurements in women living in areas with high burden of infection should be developed and validated within this project. The new method will allow accurate measurement of long term oral iron absorption and the estimation of iron requirements, potentially providing fundamental guidance for supplementation and fortification programs in sub-Saharan Africa. In a case series with four months' preventative iron supplementation intervention imbedded between a four months' control period prior intervention and a four months' control period after intervention, we will follow a group of 63 women. During the intervention period, the women will receive 50 mg Fe as ferrous sulfate tablets every day for 120 d. In total, the women will give 9 blood samples (day 1, 60 120, 150, 180, 210, 240, 300 and 360) for the de-termination of the isotopic composition and iron status biomarkers and 5 stool samples (day 1, 120, 180, 240 and 360) for the detection of soil transmitted helminths and gut inflammation. This design will allow the measurement of the isotopic iron dilution to assess the total oral iron absorption during the intervention period in comparison with the control periods without the administration of additional iron isotopes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: August 31, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria

• Have participated in one of the original absorption studies

• Signed written informed consent to participate in the study

Exclusion Criteria

• Long-term medication [except contraceptives]

• Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases according to the participants own statement or examination of study doctor

• Blood losses [surgery, accident], donations or transfusions during the past 4 months before study start.

• Residence too far away [1 hour or more by motorbike] from study locations; Natitingou or Cotonou

Related Conditions & MeSH terms

• Iron Absorption

Intervention

Other:
• Eisensulfat LOMAPHARM 50 mg
Eisensulfat LOMAPHARM 50 mg administration for 120 days

Locations

Country	Name	City	State
Benin	Hôpital de zone d'Abomey-Calavi-Sô-Ava	Abomey-Calavi	Calavi
Benin	Hôpital de zone de Natitingou	Natitingou	Atacora

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Michael B. Zimmermann

Country where clinical trial is conducted

Benin, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iron isotope composition in blood		1 year