NCT02979132

Iron Long-Term Labelling Study Switzerland

Status unknown NA Last updated 9 October 2018

What this trial tests

NA trial testing Eisensulfat LOMAPHARM 50 mg in Iron Absorption in 60 participants. Status unknown.

Timeline

1 September 2017

Primary endpoint
31 July 2018

31 March 2019

Quick facts

Lead sponsor	Prof. Michael B. Zimmermann
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	60
Start date	1 September 2017
Primary completion	31 July 2018
Estimated completion	31 March 2019
Sites	1 location across Switzerland

Drugs / interventions tested

• Eisensulfat LOMAPHARM 50 mg — full drug profile →
• Ferinject(R) — full drug profile →
• iron fortified biscuits

Conditions studied

• Iron Absorption — all drugs for Iron Absorption →

Sponsor

Prof. Michael B. Zimmermann

Who can join

Adults 18 to 50, female only, with Iron Absorption. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections and are therefore of limited use in populations carrying a high burden of infection and inflammation, as for example women of reproductive age in malaria endemic areas in developing countries. Even without the confounding effect of inflammation, current markers of iron status are insensitive to small changes in dietary iron and do not allow to establish associations between dietary, lifestyle and genetic factors and iron balance. With a new method based on the dilution of a previously administered and equilibrated stable isotope signal, an accurate measurement of long-term oral iron balance and absorption is possible, allowing the estimation of iron requirements and potentially providing fundamental guidance for supplementation and fortification programs in both healthy and chronically inflamed/infected patients. In the current study the novel methodology will be validated in generally healthy subjects with low iron status. The technique will be used to assess dietary and lifestyle determinants of iron status and to compare the effect on iron balance and iron status of three distinct, commonly used iron interventions: food fortification with iron; oral iron supplementation, and intravenous iron infusion.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Direct assessment of body iron balance in women with and without iron supplementation using a long-term isotope dilution method in Benin and Switzerland.
   Speich C, Mitchikpè CES, Cercamondi CI, Zeder C, et al · · 2021 · cited 8× · PMID 33693464 · DOI 10.1093/ajcn/nqaa433