- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216030
IP Peru, Bioavailability of Iron From Potatoes (IPPERU)
May 11, 2020 updated by: Swiss Federal Institute of Technology
Iron Bioavailability From Iron Bio-fortified Irish Potato in Peruvian Women Between 18-25 Years of Age.
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lima, Peru, 1506
- Instituto de Investigacion Nutricional
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High iron Irish potato
Meal sequence B, IP High Fe
|
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
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500 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
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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
|
Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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).
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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
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Reyna Liria, INN
- Principal Investigator: Mary Penny, INN
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 14, 2019
Primary Completion (Actual)
August 8, 2019
Study Completion (Actual)
August 8, 2019
Study Registration Dates
First Submitted
December 29, 2019
First Submitted That Met QC Criteria
December 29, 2019
First Posted (Actual)
January 2, 2020
Study Record Updates
Last Update Posted (Actual)
May 13, 2020
Last Update Submitted That Met QC Criteria
May 11, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1267-USAI-000-ETH-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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