Clinical Trials Directory

Trials / Completed

CompletedNCT04216030

IP Peru, Bioavailability of Iron From Potatoes

Iron Bioavailability From Iron Bio-fortified Irish Potato in Peruvian Women Between 18-25 Years of Age.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Swiss Federal Institute of Technology · Academic / Other
Sex
Female
Age
18 Years – 25 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 Irish Potato (IP) 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 IP variety and a normal market level IP variety. The study is conducted in Peruvian women of reproductive age with marginal iron status.

Detailed description

The 40 women enrolled will consume test meals consisting of 500g steamed and mashed high iron Irish 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, study day 15 (before switching to the other test meal IP variety), 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

Interventions

TypeNameDescription
OTHERHigh Fe IP meal labelled with Fe-58500 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
OTHERControl OFSP meal labelled with Fe-57500 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days

Timeline

Start date
2019-05-14
Primary completion
2019-08-08
Completion
2019-08-08
First posted
2020-01-02
Last updated
2020-05-13

Locations

1 site across 1 country: Peru

Source: ClinicalTrials.gov record NCT04216030. Inclusion in this directory is not an endorsement.