Status:
COMPLETED
Effects of Enhancers and Inhibitors on Absorption From Iron Supplements
Lead Sponsor:
Swiss Federal Institute of Technology
Conditions:
Iron-deficiency
Iron Deficiency Anemia
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Iron deficiency (ID) is a major public health problem worldwide and oral iron supplementation can be an effective strategy to treat and prevent ID. To maximize iron bioavailability form oral iron supp...
Eligibility Criteria
Inclusion
- Female, 18 to 45 years old,
- SF levels \<30 μg/L,
- Body weight \< 70 kg
- Normal Body Mass Index (18.5-25 kg/m2),
- Signed informed consent.
Exclusion
- Anemia (Hb \< 12 g/dL)
- Elevated CRP \> 5 mg/L,
- Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) affecting iron metabolism,
- Continuous/long-term use of medication during the whole study, which may interfere with iron absorption, gut physiology and iron metabolism,
- Consumption of mineral and vitamin supplements since screening and over the study period until last blood sample collection,
- Difficulties with blood sampling,
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months,
- Known hypersensitivity or allergy to iron capsules in the given amount (ferrous fumarate, brilliant blue FCF (E133), titandioxide (E171) and sodium lauryl sulfate)
- Pregnancy, breastfeeding
- Women who intend to become pregnant during the course of the study,
- Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse,
- Smokers (\> 1 cigarette per week),
- Participant is likely to be absent on one the study appointments,
- Inability to follow the procedures of the study, e.g. due to language problems, self-reported psychological disorders, etc. of the participant.
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05414474
Start Date
June 20 2022
End Date
December 9 2022
Last Update
January 25 2024
Active Locations (1)
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1
ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and Health
Zurich, Switzerland, 8092