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

Sponsors

Lead Sponsor: Swiss Federal Institute of Technology

Source Swiss Federal Institute of Technology
Brief Summary

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.

Overall Status Completed
Start Date October 10, 2017
Completion Date June 30, 2018
Primary Completion Date January 8, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Fractional and total iron absorption absorption will be measured 14days after the 100mg and 200mg cycle
Serum hepcidin right before the administration of an iron dose
Serum EPO right before the administration of an iron dose
Secondary Outcome
Measure Time Frame
Serum ferritin right before the administration of an iron dose
Serum TfR right before the administration of an iron dose
Serum CRP right before the administration of an iron dose
Serum AGP right before the administration of an iron dose
Serum iron right before the administration of an iron dose
Total iron binding capacity right before the administration of an iron dose
Enrollment 20
Condition
Intervention

Intervention Type: Other

Intervention Name: Iron stable isotope labeled iron(II) sulfate

Description: Administration of oral stable isotope labels using different dosings and different regimens in women with iron deficiency anemia

Arm Group Label: Stable isotope labeled iron II sulfate

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Human Nutrition Laboratory ETH Zurich
Location Countries

Switzerland

Verification Date

August 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Swiss Federal Institute of Technology

Investigator Full Name: Prof. Michael B. Zimmermann

Investigator Title: Prof. Dr. med

Has Expanded Access No
Condition Browse
Arm Group

Label: Stable isotope labeled iron II sulfate

Description: 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.

Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov