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Trial record 64 of 110 for:    test | ( Map: Malawi )

Bio Fortified Iron OFSP Malawi (SASHA-II)

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ClinicalTrials.gov Identifier: NCT03840031
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
College of Medicine, Department of Public Health, University of Malawi, TRUE
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

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, we need to assess the iron bioavailability of the new biofortified breed. In our study this is the iron from a new bio fortified Orange Fleshed Sweet Potato breed.

In this study we compare the fractional and total iron absorption of a normal Orange Flesh Sweet Potato variety and a high-iron bio fortified variety in Malawian women of reproductive age with marginal iron status.


Condition or disease Intervention/treatment Phase
Iron-deficiency Iron Deficiency Anemia Other: Orange Flesh Sweet Potato High Iron and Orange Flesh Sweet Potato Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each woman consumes both orange flesh sweet potato varieties
Masking: Single (Participant)
Masking Description: Participant is blinded, meal option A or B
Primary Purpose: Prevention
Official Title: SASHA-II Iron Bioavailability From Iron-bio Fortified Orange Fleshed Sweet Potato in Malawian Women Between 18-35 Years
Estimated Study Start Date : February 11, 2019
Estimated Primary Completion Date : February 25, 2019
Estimated Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Orange Flesh Sweet Potato High Iron
Meal consumption with Orange Flesh Sweet Potato bio fortified High Iron variety
Other: Orange Flesh Sweet Potato High Iron and Orange Flesh Sweet Potato Control
meal feedings with steamed Orange Flesh Sweet Potato bio fortified High Iron with extrinsic iron isotope labelling or meal feedings with steamed Orange Flesh Sweet Potato control variety with extrinsic iron isotope labelling

Orange Flesh Sweet Potato Control
Meal consumption with normal Orange Flesh Sweet Potato variety
Other: Orange Flesh Sweet Potato High Iron and Orange Flesh Sweet Potato Control
meal feedings with steamed Orange Flesh Sweet Potato bio fortified High Iron with extrinsic iron isotope labelling or meal feedings with steamed Orange Flesh Sweet Potato control variety with extrinsic iron isotope labelling




Primary Outcome Measures :
  1. Fractional iron absorption [ Time Frame: Intervention day 40 ]
    Fractional iron absorption from both Orange Flesh Sweet Potato varieties, extrinsic labelled with iron isotopes.

  2. Total iron absorption [ Time Frame: Intervention day 40 ]
    Total iron absorption from both Orange Flesh Sweet Potato varieties, extrinsic labelled with iron isotopes.


Secondary Outcome Measures :
  1. Plasma Ferritin/ other iron status markers [ Time Frame: Intervention day 40 ]
    Plasma Ferritin and other iron status markers



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on health passport or birth certificate.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Woman aged 18-35 years old
  2. low/marginal iron status respectively evidenced by one of the following criteria: PF

    ≤ 25 µg/L

  3. Normal BMI for age (18.5-25.0 kg/m2)
  4. 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.
  5. Living in a study radius of 30 km from the meal distribution/ health centre side
  6. Willing and able to commute to the set meal distribution/ health centre side
  7. Able to understand and to sign* written concept prior to trial entry
  8. Informed consent signed * Signing of informed consent by either autograph or finger print.

Exclusion Criteria:

  1. Severe anaemia Hb <80 g/l
  2. High infection rate based on CRP > 5 mg/Dl
  3. Any known chronic diseases
  4. Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
  5. Diagnosed food allergy.
  6. Pregnancy (urine test during screening
  7. Lactation.
  8. History of cancer within the past year, from self-report by the woman or as obtained from her health passport
  9. Any medication or supplement which may impact erythrocytes, Hb or haematocrit (to the opinion of the investigator).
  10. Iron supplementation therapy or perfusion in the last three months
  11. 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)
  12. Have a high alcohol consumption (more than 2 drinks/day).
  13. Consumption of illicit drugs based on reported use (based on anamnesis only).
  14. Subject having a hierarchical link with the investigator or co-investigators.
  15. Fever (body temperature >37.5 °C), on day 1 of the feeding scheme
  16. Subject who cannot be expected to comply with treatment (malaria or helminths) or study procedure.
  17. Currently participating or having participated in another clinical trial during the past month prior to the beginning of this study.
  18. Enrolment in any (micronutrient) food program
  19. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840031


Locations
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Malawi
Training and Research Unit of Excellence, University of Malawi
Zomba, Malawi
Switzerland
ETH Zürich, Laboratory of Human Nutrition
Zürich, ZH, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
College of Medicine, Department of Public Health, University of Malawi, TRUE

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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT03840031     History of Changes
Other Study ID Numbers: SASHA-II
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Federal Institute of Technology:
Biofortification
Orange flesh sweet potato
Stable isotope studies

Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs