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IP Peru, Bioavailability of Iron From Potatoes (IPPERU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216030
Recruitment Status : Completed
First Posted : January 2, 2020
Last Update Posted : May 13, 2020
Sponsor:
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
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

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.

Condition or disease Intervention/treatment Phase
Iron-deficiency Iron Deficiency Anemia Iron Deficiency (Without Anemia) Other: High Fe IP meal labelled with Fe-58 Other: Control OFSP meal labelled with Fe-57 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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.
Primary Purpose: Prevention
Official Title: Iron Bioavailability From Iron Bio-fortified Irish Potato in Peruvian Women Between 18-25 Years of Age.
Actual Study Start Date : May 14, 2019
Actual Primary Completion Date : August 8, 2019
Actual Study Completion Date : August 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: High iron Irish potato
Meal sequence B, IP High Fe
Other: High Fe IP meal labelled with Fe-58
500 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days

Active Comparator: Regular Irish potato
Meal sequence A, OFSP control
Other: Control OFSP meal labelled with Fe-57
500 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Woman aged 18-25 years old.
  2. Low/marginal iron status: serum ferritin (SF) ≤ 25 μg/L.
  3. Normal BMI for age (18.5-25.0 kg/m2).
  4. 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.
  5. Willing and able to commute to the meal distribution/health centre site.
  6. Able to understand and to sign written concept prior to trial entry.
  7. Informed consent signed.
  8. Prepared to use contraceptives for the duration of the study

Exclusion Criteria:

  1. Severe anaemia Hb <107.2 g/L (adjusted for meters above sea level)
  2. Inflammation/infection (CRP > 5 mg/100 ml).
  3. 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.
  4. Pregnant (urine test before entering the study) or breast-feeding.
  5. Any medication or supplement which may impact iron metabolism.
  6. Unwilling to discontinue vitamin and minerals supplements at least two weeks prior to the study start, as ascertained at the screening visit.
  7. Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation).
  8. Subject who cannot be expected to comply with study procedures.
  9. Presence of fever (>37.5 °C) on the first study day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216030


Locations
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Peru
Instituto de Investigacion Nutricional
Lima, Peru, 1506
Sponsors and Collaborators
Swiss Federal Institute of Technology
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
Investigators
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Principal Investigator: Reyna Liria INN
Principal Investigator: Mary Penny INN
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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT04216030    
Other Study ID Numbers: 1267-USAI-000-ETH-01
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swiss Federal Institute of Technology:
Biofortification
Staple crops
Stable isotope studies
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases