Status:
COMPLETED
Iron Bioavailability From Biofortified Orange-fleshed Sweet Potato
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
University of Malawi
Conditions:
Iron-deficiency
Iron Deficiency Anemia
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
To combat iron deficiency in Low and Middle-Income Countries, sustainable food-based solutions have to be implemented to serve populations, not only individuals. One solution is the introduction of ir...
Detailed Description
The 25 women enrolled will consume test meals consisting of 400g steamed and mashed high iron sweet potatoes labelled with Fe-58 daily for a period of 10 days and will then switch to the test meals co...
Eligibility Criteria
Inclusion
- Woman aged 18-35 years old
- low/marginal iron status respectively evidenced by one of the following criteria: PF ≤ 25 µg/L
- Normal BMI for age (18.5-25.0 kg/m2)
- Weight less than 65 kg. A maximum weight limitation is needed since the stable isotope portions are based on body weight. We want to give equal amounts of stable isotopes to each study participant and therefore need to standardize body weight.
- Living in a study radius of 30 km from the meal distribution/ health centre side
- Willing and able to commute to the set meal distribution/ health centre side
- Able to understand and to sign\* written concept prior to trial entry
- Informed consent signed \* Signing of informed consent by either autograph or finger print.
Exclusion
- Severe anaemia Hb \<80 g/l
- High infection rate based on CRP \> 5 mg/L
- Any known chronic diseases
- Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
- Diagnosed food allergy.
- Pregnancy (urine test during screening
- Lactation.
- History of cancer within the past year, from self-report by the woman or as obtained from her health passport
- Any medication or supplement which may impact erythrocytes, Hb or haematocrit (to the opinion of the investigator).
- Iron supplementation therapy or perfusion in the last three months
- Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation or other cause influencing blood volume to be investigated by the PI)
- Have a high alcohol consumption (more than 2 drinks/day).
- Consumption of illicit drugs based on reported use (based on anamnesis only).
- Subject having a hierarchical link with the investigator or co-investigators.
- Fever (body temperature \>37.5 °C), on day 1 of the feeding scheme
- Subject who cannot be expected to comply with treatment (malaria or helminths) or study procedure.
- Currently participating or having participated in another clinical trial during the past month prior to the beginning of this study.
- Enrolment in any (micronutrient) food program
- Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03840031
Start Date
March 25 2019
End Date
May 3 2019
Last Update
November 25 2019
Active Locations (2)
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1
Training and Research Unit of Excellence, University of Malawi
Zomba, Malawi
2
Swiss Federal Institute of Technology, Laboratory of Human Nutrition
Zurich, Canton of Zurich, Switzerland, 8092