Iron Long-Term Labelling Study Benin

NCT ID: NCT02979080

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-10
• Study Completion Date: 2019-08-31

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 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.

Conditions

Iron Absorption

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Oral Iron Supplementation

Eisensulfat LOMAPHARM 50 mg administration for 120 days

Group Type: EXPERIMENTAL

Eisensulfat LOMAPHARM 50 mg

Intervention Type: OTHER

Eisensulfat LOMAPHARM 50 mg administration for 120 days

Interventions

Eisensulfat LOMAPHARM 50 mg

Eisensulfat LOMAPHARM 50 mg administration for 120 days

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Michael B. Zimmermann

OTHER

Sponsor Role: lead

Responsible Party

Prof. Michael B. Zimmermann

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hôpital de zone de Natitingou

Natitingou, Atakora Department, Benin

Hôpital de zone d'Abomey-Calavi-Sô-Ava

Abomey-Calavi, Calavi, Benin

Countries

Benin

References

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.

Reference Type: DERIVED

PMID: 33693464 (View on PubMed)

Other Identifiers

Fe_LTL_Be

Identifier Type: -

Identifier Source: org_study_id