Iron Absorption From Tef-injera in Women of Reproductive Age

October 11, 2013 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron absorption
Time Frame: 17 days
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.
17 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (Estimate)

September 18, 2012

Study Record Updates

Last Update Posted (Estimate)

October 14, 2013

Last Update Submitted That Met QC Criteria

October 11, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK2012N31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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