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Status unknownNCT02979080Updated Oct 9, 2018

Iron Long-Term Labelling Study Benin

An interventional study of Eisensulfat LOMAPHARM 50 mg in Iron Absorption, sponsored by Prof. Michael B. Zimmermann. Status unknown at 2 sites in Benin. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Prof. Michael B. Zimmermann · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Iron Absorption
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Have participated in one of the original absorption studies
  • Signed written informed consent to participate in the study

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (estimated)

Study arms

  • Experimental
    Oral Iron Supplementation

    Eisensulfat LOMAPHARM 50 mg administration for 120 days

    Other: Eisensulfat LOMAPHARM 50 mg

Interventions

  • OtherEisensulfat LOMAPHARM 50 mg

    Eisensulfat LOMAPHARM 50 mg administration for 120 days

05

What researchers measure

Primary outcomes

  1. iron isotope composition in blood

    Time frame: 1 year

06

Study locations

2 sites
  • Hôpital de zone de Natitingou
    Natitingou, Atacora, Benin
  • Hôpital de zone d'Abomey-Calavi-Sô-Ava
    Abomey-Calavi, Calavi, Benin
07

References and documents

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. PubMed 33693464 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT02979080
Lead sponsor
Prof. Michael B. Zimmermann
Responsible party
Prof. Michael B. Zimmermann (Professor, Swiss Federal Institute of Technology) — Sponsor-investigator
First posted
Dec 1, 2016
Start date
Jun 10, 2017
Primary completion
Jun 30, 2018
Completion
Aug 31, 2019 (estimated)
Last update
Oct 9, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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