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Completed

NCT Number: NCT04216030

IP Peru, Bioavailability of Iron From Potatoes

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.

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Key information

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Investigacion Nutricional

Lima, 1506, Peru

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Woman aged 18-25 years old.
  • Low/marginal iron status: serum ferritin (SF) ≤ 25 μg/L.
  • Normal BMI for age (18.5-25.0 kg/m2).
  • Weight less than 65 kg. We will give equal amounts of stable isotopes to each study participant and therefore need to set a limit on body weight in order to achieve measurable isotope enrichment in erythrocytes.
  • Willing and able to commute to the meal distribution/health centre site.
  • Able to understand and to sign written concept prior to trial entry.
  • Informed consent signed.
  • Prepared to use contraceptives for the duration of the study

Exclusion criteria

  • Severe anaemia Hb <107.2 g/L (adjusted for meters above sea level)
  • Inflammation/infection (CRP > 5 mg/100 ml).
  • Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, and any other problem that will interfere with the study as determined by the screening visit and by self-report from the subjects.
  • Pregnant (urine test before entering the study) or breast-feeding.
  • Any medication or supplement which may impact iron metabolism.
  • Unwilling to discontinue vitamin and minerals supplements at least two weeks prior to the study start, as ascertained at the screening visit.
  • Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation).
  • Subject who cannot be expected to comply with study procedures.
  • Presence of fever (>37.5 °C) on the first study day

Treatment and study plan

High Fe IP meal labelled with Fe-58

Other

500 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days

Control OFSP meal labelled with Fe-57

Other

500 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days

Primary outcomes

  1. Fractional iron absorption from both Irish Potato test meals

    Time frame: Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.

    Proportion of stable isotope administered with test meals that has been incorporate into erythrocytes 14 days after completion of specific test meal feeding period

  2. Total iron absorption from both Irish Potato test meals

    Time frame: Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.

    Amount of iron absorbed (mg) from the labelled test meals

Secondary outcomes

  1. Concentration of plasma ferritin level

    Time frame: screening (-1), day 1 (baseline), day 15 (before switch to other test meal type) day 26 (last feeding day) and day 40 (14 days after last test meal consumption).

    Iron status marker

  2. Concentration of plasma CRP level

    Time frame: screening (-1), day 1 (baseline), day 15 (before switch to other test meal type) day 26 (last feeding day) and day 40 (14 days after last test meal consumption).

    Inflammation status marker

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Genetics, Genomics and Crop Improvement Program, International Potato Center, Lima, Peru
  • Instituto de Investigacion Nutricional, Lima, Peru
  • Quadram Institute Bioscience
  • United States Agency for International Development (USAID)

Registry information

Official study title

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

Acronym: IPPERU

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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