Iron-deficiencyIPPERUNCT04216030
IP Peru, Bioavailability of Iron From Potatoes
A study testing High Fe IP meal labelled with Fe-58 in people with Iron-deficiency and Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency (Without Anemia)
- What is being tested?
- High Fe IP meal labelled with Fe-58
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePeru
- Study dates
- 14 May 2019to 8 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- High Fe IP meal labelled with Fe-58, Control OFSP meal labelled with Fe-57
- Keywords
- Biofortification, Staple crops, Stable isotope studies
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fe IP meal labelled with Fe-58Other
500 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
Control OFSP meal labelled with Fe-57Other
500 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| High iron Irish potato | Experimental | Meal sequence B, IP High Fe Receives: Other: High Fe IP meal labelled with Fe-58 |
| Regular Irish potato | Active comparator | Meal sequence A, OFSP control Receives: Other: Control OFSP meal labelled with Fe-57 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
Total iron absorption from both Irish Potato test meals
Amount of iron absorbed (mg) from the labelled test meals
Measured: Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
Secondary outcomes (2)
Concentration of plasma ferritin level
Iron status marker
Measured: 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).
Concentration of plasma CRP level
Inflammation status marker
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start14 May 2019
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each woman consumes both high-iron Irish potato and a regular Irish potato variety.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- 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, Peru
- Responsible party
- Sponsor
- Investigators
- Reyna Liria, Principal investigator, INNMary Penny, Principal investigator, INN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216030
- Sponsor's protocol ID
- 1267-USAI-000-ETH-01
- Acronym
- IPPERU
- Status last verified
- May 2020
- First submitted
- 29 Dec 2019
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33188398
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Bioavailability From Iron Bio-fortified Irish Potato in Peruvian Women Between 18-25 Years of Age.
- ClinicalTrials.gov ID
- NCT04216030
- Acronym / sponsor ID
- IPPERU / 1267-USAI-000-ETH-01
- Keywords
- Biofortification, Staple crops, Stable isotope studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- 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, Peru
- Study start
- 14 May 2019 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each woman consumes both high-iron Irish potato and a regular Irish potato variety.
| Arm | Type | Receives |
|---|---|---|
| High iron Irish potato | Experimental | Other: High Fe IP meal labelled with Fe-58Meal sequence B, IP High Fe |
| Regular Irish potato | Active comparator | Other: Control OFSP meal labelled with Fe-57Meal sequence A, OFSP control |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Fe IP meal labelled with Fe-58500 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days | Other | High iron Irish potato |
| Control OFSP meal labelled with Fe-57500 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days | Other | Regular Irish potato |
Primary outcome
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
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
2 secondary outcomes
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Derived from this study: PubMed 33188398Jongstra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reyna Liria principal investigator
INN
Mary Penny principal investigator
INN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fe IP meal labelled with Fe-58 in people with Iron-deficiency and Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.