NCT03840031

Iron Bioavailability From Biofortified Orange-fleshed Sweet Potato

SASHA-II Iron Bioavailability From Iron-biofortified Orange Fleshed Sweet Potato in Malawian Women Between 18-35 Years

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Swiss Federal Institute of Technology · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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 iron biofortified staple crops on market level. Before market level introduction, the bioavailability of iron in the new biofortified Orange Fleshed Sweet Potato (OFSP) breed needs to be assessed. In this study the investigator compares the fractional and total iron absorption after extrinsic stable isotope labelling of the new biofortified high iron OFSP variety and a normal market level OFSP variety. The study is conducted in Malawian women of reproductive age with marginal iron status.

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 consisting of 400g steamed and mashed control sweet potatoes labelled with Fe-57 for a period of 10 days. The order of test meal type is random. A baseline blood sample will be taken on the first meal feeding day prior to consumption of any test meals, on study day 26 (14 days after completion of the first test meal period) and on Day 40 (14 days after completion of the second test meal period). Erythrocyte incorporation of the stable isotope labels will be measured in these blood samples using an ICPMS and will be used to calculate fractional and total iron absorption from the two different type of test meals.

Conditions

• Iron-deficiency
• Iron Deficiency Anemia

Interventions

Type	Name	Description
OTHER	High Fe OFSP meal labelled with Fe-58	400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
OTHER	Control OFSP meal labelled with Fe-57	400 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days

Timeline

• Start date: 2019-03-25
• Primary completion: 2019-05-03
• Completion: 2019-05-03
• First posted: 2019-02-15
• Last updated: 2019-11-25

Locations

2 sites across 2 countries: Malawi, Switzerland