Status:
COMPLETED
Iron Absorption From Encapsulated Iron Sulphate in Microspheres
Lead Sponsor:
Swiss Federal Institute of Technology
Conditions:
Iron-deficiency
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Food fortification has shown to be efficacious to alleviate the burden of micronutrient deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fort...
Eligibility Criteria
Inclusion
- Female, 18 to 40 years old
- Marginal iron status (PF \<25 ng/ml)
- Body weight \< 65 kg
- Normal body Mass Index (18.5 - 25 kg/m2)
- Signed informed consent
Exclusion
- Pregnancy (assessed by a pregnancy test) / intention to become pregnant
- Lactating up to 6 weeks before study initiation
- Moderate or severe anaemia (Hb \< 9.0 g/dL)
- Elevated C reactive Protein (CRP) (\> 5.0 mg/L)
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole study (except for contraceptives)
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
- Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days
- Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)
Key Trial Info
Start Date :
April 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03332602
Start Date
April 4 2018
End Date
August 20 2018
Last Update
August 31 2018
Active Locations (1)
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1
Human Nutrition Laboratory, ETH Zurich
Zurich, Switzerland, 8092