- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03840031
Iron Bioavailability From Biofortified Orange-fleshed Sweet Potato (SASHA-II)
November 21, 2019 updated by: Swiss Federal Institute of Technology
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
25
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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Zomba, Malawi
- Training and Research Unit of Excellence, University of Malawi
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ZH
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Zürich, ZH, Switzerland, 8092
- Swiss Federal Institute of Technology, Laboratory of Human Nutrition
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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 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Orange Fleshed Sweet Potato High Iron
Meal sequence B, OFSP High Fe
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400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
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ACTIVE_COMPARATOR: Orange Fleshed Sweet Potato Control
Meal sequence A, OFSP control
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400 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 Orange Fleshed Sweet Potato varieties
Time Frame: Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
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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 Orange Fleshed Sweet Potato varieties
Time Frame: Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
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Amount of iron absorbed (mg) from the labelled test meals
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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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Iron status marker
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screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
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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)
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Inflammation status marker
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screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael Zimmermann, Prof., Swiss Federal Institute of Technology
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)
March 25, 2019
Primary Completion (ACTUAL)
May 3, 2019
Study Completion (ACTUAL)
May 3, 2019
Study Registration Dates
First Submitted
February 11, 2019
First Submitted That Met QC Criteria
February 12, 2019
First Posted (ACTUAL)
February 15, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 25, 2019
Last Update Submitted That Met QC Criteria
November 21, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SASHA-II
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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