Iron Absorption From Regular, Biofortified and Post-harvest Fortified Pearl Millet

This study has been completed.
Sponsor:
Collaborator:
Université d'Abomey-Calavi
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01634932
First received: July 3, 2012
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

Iron deficiency (ID) with or without anemia is still a main public health problem in sub-Saharan Africa and Southern Asia, especially in vulnerable population groups such as children below 5 years of age and women of reproductive age. The etiology of ID is multifactorial; but major causes are low iron dietary bioavailability and intake from monotonous cereal-based diets aggravated by chronic parasitic infections such as malaria and soil-transmitted helminthes. Approaches such as dietary diversification, supplementation with pharmacological iron doses, public health measures (e.g. deworming, malaria control) and food fortification with different iron compounds have notably reduced morbidity and mortality caused by ID but have not been universally successful. Biofortification is a new promising approach to combat micronutrient deficiencies such as ID. It is defined as the process of increasing the content and bioavailability of essential nutrients such as iron in crops by traditional plant breeding and/or genetic engineering. Pearl millet is a staple food for many people living in different areas of West Africa (e.g. Northern Benin) and India, two parts of the world, where ID is still widely prevalent. Therefore, pearl millet was one of the crops targeted for iron biofortification by HarvestPlus.

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.


Condition Intervention
Iron Deficiency
Biofortification
Other: Regular iron
Other: Iron biofortified millet
Other: Post-harvest iron-fortifed millet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Comparison of Iron Absorption From Regular-iron, Iron Biofortified, and Post-harvest Iron-fortified Pearl Millet Using Multiple Meals in Young Women

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • Iron isotope ratio in blood samples [ Time Frame: Study day 33 (32 days after administration of isotopic label in the first test meal/End of the study) ] [ Designated as safety issue: No ]

    Whole blood samples will be collected to measure the shift in iron isotope ratios 32 days after administration of isotopic label in the first test meal.

    First test meal on study days 1-5, Second test meal on study day 8-12 after a 2-day break, Third (last) test meal on study days 15-19 after a 2-day break, Measurement of iron isotopic shift in blood samples collected on study day 33 (14 days after the last test meal)



Enrollment: 22
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: regular-iron millet Other: 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
Experimental: iron-biofortified millet Other: 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
Experimental: Post-harvest iron-fortified millet Other: 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

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females of reproductive age, 18-30 years
  • 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:

  • Pregnancy or Lactating (assessed by pregnancy test)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01634932

Locations
Benin
Hopital du Zone de Natitingou
Natitingou, Atacora, Benin
Sponsors and Collaborators
Swiss Federal Institute of Technology
Université d'Abomey-Calavi
  More Information

No publications provided

Responsible Party: Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01634932     History of Changes
Other Study ID Numbers: Fe_Biofortified_Millet
Study First Received: July 3, 2012
Last Updated: November 7, 2012
Health Authority: Benin: Comité National Provisoire d'Ethique pour la Recherche en Santé

Keywords provided by Swiss Federal Institute of Technology:
Iron deficiency
Biofortification
Pearl Millet
Benin

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

ClinicalTrials.gov processed this record on September 22, 2014