Iron Absorption From Regular, Biofortified and Post-harvest Fortified Pearl Millet
NCT ID: NCT01634932
Last Updated: 2012-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2012-07-31
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To improve human iron status successfully, the additional iron gained through biofortification has to be at least as bioavailable as the iron in regular peal millet varieties. For that reason we are planning an iron absorption study where we will investigate the iron bioavailability from an iron-biofortified millet variety and compare it with the iron bioavailability from a regular-iron millet variety and from regular-iron millet fortified post-harvest with ferrous sulfate (FeSO4). Iron absorption will be determined by incorporation of labeled iron into erythrocytes, at least 14 days after the administration of the test meals containing labeled iron (stable isotope technique). The three different test meals based on 1) regular-iron, 2) iron-biofortified and 3) post-harvest iron-fortified millet will be administered as multiple meals i.e. each study participant will consume each test meal for a period of 5 days (2 portions/day; one in the morning, one for lunch). Twenty apparently healthy Beninese women with a low/marginal iron status (serum ferritin \< 25 ;g/L), non-anemic or mildly anemic (hemoglobin \>90 g/L), 18-30 years of age with a body weight \< 65 kg and normal body mass index will be included in the study.
The results of the study will provide important insights on the iron bioavailability from regular, biofortified and post-harvest fortified staple crops such as pearl millet when feeding multiple meals as part of a more complex diet. The results can be applied to different meals based on pearl millet such as the West African millet pastes or the Indian flat breads.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
regular-iron millet
Regular iron
Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
iron-biofortified millet
Iron biofortified millet
Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
Post-harvest iron-fortified millet
Post-harvest iron-fortifed millet
Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Regular iron
Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
Iron biofortified millet
Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
Post-harvest iron-fortifed millet
Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Low/marginal iron status (Hb \> 9.0 g/dl, SF \< 25 ;g/L)
* Maximum body weight 65 kg
* Normal body mass index (18.5-25 kg/m2)
* Obtained consent
Exclusion Criteria
* Fever (body temperature \>37.5 °C)
* Symptomatic malaria infection (positive blood smear for Plasmodium species + symptoms)
* Infection with soil-transmitted helminthes (positive stool samples and/or urine samples)
* Intake of mineral/vitamin supplements 2 weeks before and during the study
* Metabolic or gastrointestinal disorders, eating disorders or food allergy
* Regular intake of medication
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months
* Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
* Former participation in a study involving administration of iron stable isotopes
* Subject who cannot be expected to comply with study protocol
18 Years
30 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Université d'Abomey-Calavi
OTHER
Swiss Federal Institute of Technology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Michael B. Zimmermann
Prof
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hopital du Zone de Natitingou
Natitingou, Atakora Department, Benin
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Fe_Biofortified_Millet
Identifier Type: -
Identifier Source: org_study_id