Iron-deficiencySASHA-IINCT03840031
Iron Bioavailability From Biofortified Orange-fleshed Sweet Potato
A study testing High Fe OFSP meal labelled with Fe-58 in people with Iron-deficiency and Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
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 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia
- What is being tested?
- High Fe OFSP meal labelled with Fe-58
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Mar 2019to 3 May 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman aged 18-35 years old
- low/marginal iron status respectively evidenced by one of the following criteria: PF ≤ 25 µg/L
- Normal BMI for age (18.5-25.0 kg/m2)
- Weight less than 65 kg. A maximum weight limitation is needed since the stable isotope portions are based on body weight. We want to give equal amounts of stable isotopes to each study participant and therefore need to standardize body weight.
- Living in a study radius of 30 km from the meal distribution/ health centre side
- Willing and able to commute to the set meal distribution/ health centre side
- Able to understand and to sign* written concept prior to trial entry
- Informed consent signed * Signing of informed consent by either autograph or finger print.
Who cannot join
- Severe anaemia Hb <80 g/l
- High infection rate based on CRP > 5 mg/L
- Any known chronic diseases
- Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
- Diagnosed food allergy.
- Pregnancy (urine test during screening
Show all 19Show fewer
- Lactation.
- History of cancer within the past year, from self-report by the woman or as obtained from her health passport
- Any medication or supplement which may impact erythrocytes, Hb or haematocrit (to the opinion of the investigator).
- Iron supplementation therapy or perfusion in the last three months
- Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation or other cause influencing blood volume to be investigated by the PI)
- Have a high alcohol consumption (more than 2 drinks/day).
- Consumption of illicit drugs based on reported use (based on anamnesis only).
- Subject having a hierarchical link with the investigator or co-investigators.
- Fever (body temperature >37.5 °C), on day 1 of the feeding scheme
- Subject who cannot be expected to comply with treatment (malaria or helminths) or study procedure.
- Currently participating or having participated in another clinical trial during the past month prior to the beginning of this study.
- Enrolment in any (micronutrient) food program
- Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Malawi1 site
Training and Research Unit of Excellence, University of Malawi
Zomba
Switzerland1 site
Swiss Federal Institute of Technology, Laboratory of Human Nutrition
Zurich, Canton of Zurich, 8092
About this study
Official title: SASHA-II Iron Bioavailability From Iron-biofortified Orange Fleshed Sweet Potato in Malawian Women Between 18-35 Years
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 Orange Fleshed Sweet Potato (OFSP) 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 OFSP variety and a normal market level OFSP variety. The study is conducted in Malawian women of reproductive age with marginal iron status.
Read the detailed description
The 25 women enrolled will consume test meals consisting of 400g steamed and mashed high iron sweet 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, 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.
- Conditions
- Iron-deficiency, Iron Deficiency Anemia
- Being tested
- High Fe OFSP meal labelled with Fe-58, Control OFSP meal labelled with Fe-57
- Keywords
- Biofortification, Orange fleshed sweet potato, Stable isotope studies
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fe OFSP meal labelled with Fe-58Other
400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
Control OFSP meal labelled with Fe-57Other
400 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Orange Fleshed Sweet Potato High Iron | Experimental | Meal sequence B, OFSP High Fe Receives: Other: High Fe OFSP meal labelled with Fe-58 |
| Orange Fleshed Sweet Potato Control | 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 Orange Fleshed Sweet Potato varieties
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 Orange Fleshed Sweet Potato varieties
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), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
Concentration of plasma CRP level
Inflammation status marker
Measured: screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start25 Mar 2019
- Primary completion3 May 2019
- Study completion3 May 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 Orange Fleshed Sweet Potato varieties
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malawi
- Responsible party
- Sponsor
- Investigators
- Michael Zimmermann, Prof., Principal investigator, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840031
- Sponsor's protocol ID
- SASHA-II
- Acronym
- SASHA-II
- Status last verified
- Nov 2019
- First submitted
- 11 Feb 2019
- Last updated
- 25 Nov 2019
- 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 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SASHA-II Iron Bioavailability From Iron-biofortified Orange Fleshed Sweet Potato in Malawian Women Between 18-35 Years
- ClinicalTrials.gov ID
- NCT03840031
- Acronym / sponsor ID
- SASHA-II / SASHA-II
- Conditions
- Iron-deficiency, Iron Deficiency Anemia
- Keywords
- Biofortification, Orange fleshed sweet potato, Stable isotope studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Malawi
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 15 Feb 2019 (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 Orange Fleshed Sweet Potato (OFSP) 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 OFSP variety and a normal market level OFSP variety. The study is conducted in Malawian women of reproductive age with marginal iron status.
Detailed description
The 25 women enrolled will consume test meals consisting of 400g steamed and mashed high iron sweet 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, 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
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each woman consumes both Orange Fleshed Sweet Potato varieties
| Arm | Type | Receives |
|---|---|---|
| Orange Fleshed Sweet Potato High Iron | Experimental | Other: High Fe OFSP meal labelled with Fe-58Meal sequence B, OFSP High Fe |
| Orange Fleshed Sweet Potato Control | Active comparator | Other: Control OFSP meal labelled with Fe-57Meal sequence A, OFSP control |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Woman aged 18-35 years old
- low/marginal iron status respectively evidenced by one of the following criteria: PF ≤ 25 µg/L
- Normal BMI for age (18.5-25.0 kg/m2)
- Weight less than 65 kg. A maximum weight limitation is needed since the stable isotope portions are based on body weight. We want to give equal amounts of stable isotopes to each study participant and therefore need to standardize body weight.
- Living in a study radius of 30 km from the meal distribution/ health centre side
Key exclusion criteria (19 listed)
- Severe anaemia Hb <80 g/l
- High infection rate based on CRP > 5 mg/L
- Any known chronic diseases
- Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
- Diagnosed food allergy.
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 OFSP meal labelled with Fe-58400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days | Other | Orange Fleshed Sweet Potato High Iron |
| Control OFSP meal labelled with Fe-57400 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days | Other | Orange Fleshed Sweet Potato Control |
Primary outcome
Fractional iron absorption from both Orange Fleshed Sweet Potato varieties
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 Orange Fleshed Sweet Potato varieties
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), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
Concentration of plasma CRP level
Time frame: screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
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 25 Nov 2019.
- 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.
Michael Zimmermann, Prof. principal investigator
Swiss Federal Institute of Technology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fe OFSP meal labelled with Fe-58 in people with Iron-deficiency and Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
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 19 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi, Switzerland. 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 Orange Fleshed Sweet Potato varieties (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 NCT03840031, 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 25 Nov 2019.