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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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zurich

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FeSO4

Other

reduction of phytate

Other

NaFeEDTA

Other

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2013
First posted: Sep 18, 2012
Registry last updated: Oct 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed