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Iron Absorption From Tef-injera in Women of Reproductive Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01687062
First received: September 13, 2012
Last updated: October 11, 2013
Last verified: October 2013

September 13, 2012
October 11, 2013
September 2012
October 2012   (final data collection date for primary outcome measure)
Iron absorption [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Test meals with isotopic iron labels will be administrated on day 1-3. Whole blood samples will be collected on day 17 (14 after the last test meal) to analyze the iron isotope ratios.
Same as current
Complete list of historical versions of study NCT01687062 on ClinicalTrials.gov Archive Site
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Iron Absorption From Tef-injera in Women of Reproductive Age
Iron Absorption From Tef-injera in Women of Reproductive Age

Anemia is one of the most common health problems all over the world with around half of preschool-aged children (<5 years) and one third of women affected. Nutritional iron deficiency is a major reason for anemia in infants, young children and women of reproductive age who have especially high iron requirements that are difficult to meet in regions where the major diet is based on plant foods. So in Ethiopia, where injera is the major staple food. Despite high levels of iron in tef, the most favored cereal for injera, the iron bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.

The aim of this study is to determine the iron bioavailability in women from injera prepared in a traditional way and investigate the potential of methods to improve the bioavaiability. Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be evaluated. Further the potential positive impact of phytic acid reduction on the iron bioavailability will be investigated. The phytic acid reduction will be achieved in two different ways, by addition of whole grain wheat as source of phytase and addition of a commercially available microbial phytase. The studies will be conducted in healthy women using stable isotope techniques.

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Interventional
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Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Iron Deficiency
  • Other: FeSO4
  • Other: reduction of phytate
  • Other: NaFeEDTA
  • Active Comparator: FeSO4 + high phytate
    injera test meal 1 labeled with a 4 mg staple iron isotope tag
    Intervention: Other: FeSO4
  • Experimental: FeSO4 + medium phytate
    injera test meal 2 labeled with a 4 mg staple iron isotope tag
    Interventions:
    • Other: FeSO4
    • Other: reduction of phytate
  • Experimental: FeSO4 + low phytate
    injera test meal 3 labeled with a 4 mg staple iron isotope tag
    Interventions:
    • Other: FeSO4
    • Other: reduction of phytate
  • Experimental: FeSO4 + NaFeEDTA (1:1) + high phytate
    injera test meal 4 labeled with a 4 mg staple iron isotope tag
    Interventions:
    • Other: FeSO4
    • Other: NaFeEDTA
  • Experimental: FeSO4 + NaFeEDTA (1:3) + high phytate
    injera test meal 5 labeled with a 4 mg staple iron isotope tag
    Interventions:
    • Other: FeSO4
    • Other: NaFeEDTA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Reproductive age females 18-40 years
  • Maximum body weight 65 kg
  • Normal body mass index (18.5-25 kg/m2)
  • No intake of mineral/vitamin supplements 2 weeks before and during the study
  • No metabolic or gastrointestinal disorders or chronic diseases
  • Not pregnant or lactating
  • No regular intake of medication (except oral contraceptives)
  • No blood donation or significant blood loss (accident, surgery) over the past 4 months
  • Not 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
  • No former participation in a study involving administration of iron stable isotopes
  • No eating disorders or food allergy
  • Subject who can be expected and are willing to comply with study protocol
  • Having received oral and written information about the aims and procedures of the study
  • Having provided oral and written informed consent
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01687062
EK2012N31
No
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Swiss Federal Institute of Technology
Not Provided
Not Provided
Swiss Federal Institute of Technology
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP