Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623997
• Other study ID #: FeSupp_Anemia
• Status: Completed
• Start date: October 10, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2018
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2018
• Est. primary completion date: January 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Human Nutrition Laboratory ETH Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Serum hepcidin	Serum hepcidin after the administration of different doses and using different regimens	right before the administration of an iron dose
Primary	Serum EPO	Serum EPO after the administration of different doses and using different	right before the administration of an iron dose
Secondary	Serum ferritin	Determination of iron status	right before the administration of an iron dose
Secondary	Serum TfR	Determination of iron status	right before the administration of an iron dose
Secondary	Serum CRP	Determination of inflammation status	right before the administration of an iron dose
Secondary	Serum AGP	Determination of inflammation status	right before the administration of an iron dose
Secondary	Serum iron	Determination of iron status	right before the administration of an iron dose
Secondary	Total iron binding capacity	Determination of iron status	right before the administration of an iron dose