Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women

Defining Systemic Control of Iron Absorption to Optimize Oral Iron Supplementation Regiemns for Women With Iron Deficiency Anemia

Iron-deficient anaemic subjects are likely to benefit most from oral iron supplements, but supplementation schedules vary widely in clinical practice, absorption is low and compliance is poor due to mild gastrointestinal side effects. The investigators will compare iron absorption from labeled oral iron doses of 100mg and 200mg administered either on two consecutive days or on alternate days in young anemic women.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Other: Iron stable isotope labeled iron(II) sulfate

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Young women with iron-deficiency anemia

Description

Inclusion Criteria:

• Ferritin <15 µg/L
• Hb 8-11.9 g/dl
• BMI 18.5-24.9 kg/m2
• Body weight <70 kg

Exclusion Criteria:

• Severe anemia (Hb <8 g/dl)
• Elevated CRP >5.0 mg/L
• Chronic disease
• Long-term medication, except contraception
• Consumption of Mineral and Vitamin supplements within the study period
• Therapeutic iron infusion over the past 6 months
• Pregnancy or breastfeeding
• Smoking

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Stable isotope labeled iron II sulfate; All subjects will go through two iron absorption study cycles. In one cycle they get 100mg oral iron labeled with stable isotopes on two consecutive and on one alternate day and in another cycle they get 200mg oral iron labeled with stable isotopes on two consecutive and on one alternate day. Half of the subjects start with the 100mg cycle whereas the other half starts with the 200mg cycle.

Other: Iron stable isotope labeled iron(II) sulfate; Administration of oral stable isotope labels using different dosings and different regimens in women with iron deficiency anemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fractional and total iron absorption	Fractional and total iron absorption from different supplementation regimens	absorption will be measured 14days after the 100mg and 200mg cycle
Serum hepcidin	Serum hepcidin after the administration of different doses and using different regimens	right before the administration of an iron dose
Serum EPO	Serum EPO after the administration of different doses and using different	right before the administration of an iron dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum ferritin	Determination of iron status	right before the administration of an iron dose
Serum TfR	Determination of iron status	right before the administration of an iron dose
Serum CRP	Determination of inflammation status	right before the administration of an iron dose
Serum AGP	Determination of inflammation status	right before the administration of an iron dose
Serum iron	Determination of iron status	right before the administration of an iron dose
Total iron binding capacity	Determination of iron status	right before the administration of an iron dose

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology

Publications and helpful links

General Publications

• Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2017
• Primary Completion (ACTUAL): January 8, 2018
• Study Completion (ACTUAL): June 30, 2018

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (ACTUAL): August 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia
• Other Study ID Numbers: FeSupp_Anemia

Drug and device information, study documents

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