Iron Long-Term Labelling Study Switzerland

Evaluation of the Validity of a Novel Isotope Dilution Method to Assess the Iron Status and Its Changes in Swiss Women

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.

Study Overview

• Status: Unknown
• Conditions: Iron Absorption
• Intervention / Treatment: Drug: Eisensulfat LOMAPHARM 50 mg; Drug: Ferinject(R); Dietary supplement: iron fortified biscuits

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8092
      • Human Nutrition Laboratory, ETH Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Have participated in a former absorption study in our lab,
• Signed written informed consent to participate in the new study,
• Serum ferritin < 25 µg/L

Exclusion Criteria:

• Anaemia (Hb < 117 g/L),
• Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),
• Allergic or similar reactions against iron supplements,
• Known fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency,
• Known hypersensitivity to ponceau R4 and ponceau R4 aluminium salt (E124)
• Continuous/long-term use of medication during the whole study (except for contraceptives),
• Regular consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration (more than 3 consecutive days or more than 5 times within 14 days),
• Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months,
• pregnancy or breast feeding,
• Intention to become pregnant during the course of the study,
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Enrollment of the investigator, his/her family members, employees and other dependent persons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Iron Supplementation; Eisensulfat LOMAPHARM 50 mg administration for 90 days	Drug: Eisensulfat LOMAPHARM 50 mg; oral intake of an 'Eisensulfat LOMAPHARM 50 mg' tablet every morning for 90 days; Other Names: Eisentabletten
Active Comparator: Intravenous Iron Supplementation; Single-dose Ferinject(R) administration	Drug: Ferinject(R); Single-dose Ferinject(R) administration; Other Names: Iron Infusion
Active Comparator: Food Fortification with Iron; Consumption of iron-fortified biscuits (15 mg Fe in form of FeSO4) for 90 d	Dietary supplement: iron fortified biscuits; consumption of an iron-fortfied biscuit every morning for 90 days; Other Names: HUG-Biskuits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iron isotope composition in blood	tracer to tracee rate in venous blood samples at different time points	9 months

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): September 1, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Anticipated): March 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

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: Fe_LTL_Swi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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