Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Other: Iron stable isotope labeled iron(II) sulfate

• Registration Number: NCT03623997
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-10
• Study First Submitted: 2017-11-06
• Primary Completion: 2018-01-08
• Study Completion: 2018-06-30
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-09
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stable isotope labeled iron II sulfate	Iron 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serum ferritin	right before the administration of an iron dose	Determination of iron status
Serum TfR	right before the administration of an iron dose	Determination of iron status
Serum CRP	right before the administration of an iron dose	Determination of inflammation status
Serum AGP	right before the administration of an iron dose	Determination of inflammation status
Serum iron	right before the administration of an iron dose	Determination of iron status
Total iron binding capacity	right before the administration of an iron dose	Determination of iron status

Trial Locations

Locations (1)

Human Nutrition Laboratory ETH Zurich; 🇨🇭 Zurich, Switzerland