Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women

Study Overview
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Brief Summary
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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.

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

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Other: Iron stable isotope labeled iron(II) sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stable isotope labeled iron II sulfate<br>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<br>* Administration of oral stable isotope labels using different dosings and different regimens in women with iron deficiency anemia<br>|

What is the study measuring?
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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 |