Iron Long-Term Labelling Study Benin

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

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.

Study Overview

• Status: Unknown
• Conditions: Iron Absorption
• Intervention / Treatment: Other: Eisensulfat LOMAPHARM 50 mg

• Study Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Benin
  • Atacora
    • Natitingou, Atacora, Benin
      • Hôpital de zone de Natitingou
  • Calavi
    • Abomey-Calavi, Calavi, Benin
      • Hôpital de zone d'Abomey-Calavi-Sô-Ava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Iron Supplementation; Eisensulfat LOMAPHARM 50 mg administration for 120 days	Other: Eisensulfat LOMAPHARM 50 mg; Eisensulfat LOMAPHARM 50 mg administration for 120 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
iron isotope composition in blood	1 year

Collaborators and Investigators

• Sponsor: Prof. Michael B. Zimmermann

Publications and helpful links

General Publications

• Speich C, Mitchikpe CES, Cercamondi CI, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Direct assessment of body iron balance in women with and without iron supplementation using a long-term isotope dilution method in Benin and Switzerland. Am J Clin Nutr. 2021 Jun 1;113(6):1657-1669. doi: 10.1093/ajcn/nqaa433.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Fe_LTL_Be

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No