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IP Peru, Bioavailability of Iron From Potatoes (IPPERU)

Primary Purpose

Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency (Without Anemia)

Status

Completed

Phase

Not Applicable

Locations

Peru

Study Type

Interventional

Intervention

High Fe IP meal labelled with Fe-58

Control OFSP meal labelled with Fe-57

About this trial

This is an interventional prevention trial for Iron-deficiency focused on measuring Biofortification, Staple crops, Stable isotope studies

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Instituto de Investigacion Nutricional

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High iron Irish potato

Regular Irish potato

Arm Description

Meal sequence B, IP High Fe

Meal sequence A, OFSP control

Outcomes

Primary Outcome Measures

Fractional iron absorption from both Irish Potato test meals

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

Total iron absorption from both Irish Potato test meals

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

Secondary Outcome Measures

Concentration of plasma ferritin level

Iron status marker

Concentration of plasma CRP level

Inflammation status marker

Full Information

NCT ID

NCT04216030

First Posted

December 29, 2019

Last Updated

May 11, 2020

Sponsor

Swiss Federal Institute of Technology

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04216030

Brief Title

IP Peru, Bioavailability of Iron From Potatoes

Acronym

IPPERU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

May 14, 2019 (Actual)

Primary Completion Date

August 8, 2019 (Actual)

Study Completion Date

August 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Federal Institute of Technology

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency (Without Anemia)

Keywords

Biofortification, Staple crops, Stable isotope studies

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Each woman consumes both high-iron Irish potato and a regular Irish potato variety.

Masking

None (Open Label)

Masking Description

Participant is non-blinded based on differences in meal option A and B, meal option A --> B or B --> A, is assigned through investigator randomisation.

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High iron Irish potato

Arm Type

Experimental

Arm Description

Meal sequence B, IP High Fe

Arm Title

Regular Irish potato

Arm Type

Active Comparator

Arm Description

Meal sequence A, OFSP control

Intervention Type

Other

Intervention Name(s)

High Fe IP meal labelled with Fe-58

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Control OFSP meal labelled with Fe-57

Intervention Description

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

Primary Outcome Measure Information:

Title

Fractional iron absorption from both Irish Potato test meals

Description

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

Time Frame

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

Title

Total iron absorption from both Irish Potato test meals

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Concentration of plasma ferritin level

Description

Iron status marker

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).

Title

Concentration of plasma CRP level

Description

Inflammation status marker

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).

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reyna Liria

Organizational Affiliation

INN

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mary Penny

Organizational Affiliation

INN

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto de Investigacion Nutricional

City

Lima

ZIP/Postal Code

1506

Country

Peru

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33188398

Citation

Jongstra R, Mwangi MN, Burgos G, Zeder C, Low JW, Mzembe G, Liria R, Penny M, Andrade MI, Fairweather-Tait S, Zum Felde T, Campos H, Phiri KS, Zimmermann MB, Wegmuller R. Iron Absorption from Iron-Biofortified Sweetpotato Is Higher Than Regular Sweetpotato in Malawian Women while Iron Absorption from Regular and Iron-Biofortified Potatoes Is High in Peruvian Women. J Nutr. 2020 Dec 10;150(12):3094-3102. doi: 10.1093/jn/nxaa267.

Results Reference

derived

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IP Peru, Bioavailability of Iron From Potatoes

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