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
  Purpose

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.


Condition Intervention
Iron Deficiency
Other: FeSO4
Other: reduction of phytate
Other: NaFeEDTA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Iron Absorption From Tef-injera in Women of Reproductive Age

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: September 2012
Study Completion Date: October 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FeSO4 + high phytate
injera test meal 1 labeled with a 4 mg staple iron isotope tag
Other: FeSO4
Experimental: FeSO4 + medium phytate
injera test meal 2 labeled with a 4 mg staple iron isotope tag
Other: FeSO4 Other: reduction of phytate
Experimental: FeSO4 + low phytate
injera test meal 3 labeled with a 4 mg staple iron isotope tag
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
Other: FeSO4 Other: NaFeEDTA
Experimental: FeSO4 + NaFeEDTA (1:3) + high phytate
injera test meal 5 labeled with a 4 mg staple iron isotope tag
Other: FeSO4 Other: NaFeEDTA

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01687062

Locations
Switzerland
ETH Zurich
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
  More Information

No publications provided

Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01687062     History of Changes
Other Study ID Numbers: EK2012N31
Study First Received: September 13, 2012
Last Updated: October 11, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Federal Institute of Technology:
NaFeEDTA
phytate
injera
iron absorption

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Fe(III)-EDTA
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014