Iron Bioavailability From Biofortified Orange-fleshed Sweet Potato (SASHA-II)
Primary Purpose
Iron-deficiency, Iron Deficiency Anemia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
High Fe OFSP meal labelled with Fe-58
Control OFSP meal labelled with Fe-57
Sponsored by
About this trial
This is an interventional prevention trial for Iron-deficiency focused on measuring Biofortification, Orange fleshed sweet potato, Stable isotope studies
Eligibility Criteria
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.
Sites / Locations
- Training and Research Unit of Excellence, University of Malawi
- Swiss Federal Institute of Technology, Laboratory of Human Nutrition
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Orange Fleshed Sweet Potato High Iron
Orange Fleshed Sweet Potato Control
Arm Description
Meal sequence B, OFSP High Fe
Meal sequence A, OFSP control
Outcomes
Primary Outcome Measures
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
Total iron absorption from both Orange Fleshed Sweet Potato varieties
Amount of iron absorbed (mg) from the labelled test meals
Secondary Outcome Measures
Concentration of plasma ferritin level
Iron status marker
Concentration of plasma CRP level
Inflammation status marker
Full Information
NCT ID
NCT03840031
First Posted
February 11, 2019
Last Updated
November 21, 2019
Sponsor
Swiss Federal Institute of Technology
Collaborators
University of Malawi
1. Study Identification
Unique Protocol Identification Number
NCT03840031
Brief Title
Iron Bioavailability From Biofortified Orange-fleshed Sweet Potato
Acronym
SASHA-II
Official Title
SASHA-II Iron Bioavailability From Iron-biofortified Orange Fleshed Sweet Potato in Malawian Women Between 18-35 Years
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
May 3, 2019 (Actual)
Study Completion Date
May 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
University of Malawi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Iron Deficiency Anemia
Keywords
Biofortification, Orange fleshed sweet potato, Stable isotope studies
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each woman consumes both Orange Fleshed Sweet Potato varieties
Masking
Participant
Masking Description
Participant is blinded, meal option A --> B or B --> A based on investigator randomisation.
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orange Fleshed Sweet Potato High Iron
Arm Type
Experimental
Arm Description
Meal sequence B, OFSP High Fe
Arm Title
Orange Fleshed Sweet Potato Control
Arm Type
Active Comparator
Arm Description
Meal sequence A, OFSP control
Intervention Type
Other
Intervention Name(s)
High Fe OFSP meal labelled with Fe-58
Intervention Description
400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
Intervention Type
Other
Intervention Name(s)
Control OFSP meal labelled with Fe-57
Intervention Description
400 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days
Primary Outcome Measure Information:
Title
Fractional iron absorption from both Orange Fleshed Sweet Potato varieties
Description
Proportion of stable isotope administered with test meals that has been incorporate into erythrocytes 14 days after completion of specific test meal feeding period
Time Frame
Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
Title
Total iron absorption from both Orange Fleshed Sweet Potato varieties
Description
Amount of iron absorbed (mg) from the labelled test meals
Time Frame
Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
Secondary Outcome Measure Information:
Title
Concentration of plasma ferritin level
Description
Iron status marker
Time Frame
screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
Title
Concentration of plasma CRP level
Description
Inflammation status marker
Time Frame
screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Based on health passport or birth certificate.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Zimmermann, Prof.
Organizational Affiliation
Swiss Federal Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Training and Research Unit of Excellence, University of Malawi
City
Zomba
Country
Malawi
Facility Name
Swiss Federal Institute of Technology, Laboratory of Human Nutrition
City
Zürich
State/Province
ZH
ZIP/Postal Code
8092
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33188398
Citation
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.
Results Reference
derived
Learn more about this trial
Iron Bioavailability From Biofortified Orange-fleshed Sweet Potato
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