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Iron Absorption From Tef-injera in Women of Reproductive Age

NCT ID: NCT01687062

Last Updated: 2013-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Deficiency

Keywords

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NaFeEDTA phytate injera iron absorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FeSO4 + high phytate

injera test meal 1 labeled with a 4 mg staple iron isotope tag

Group Type ACTIVE_COMPARATOR

FeSO4

Intervention Type OTHER

FeSO4 + medium phytate

injera test meal 2 labeled with a 4 mg staple iron isotope tag

Group Type EXPERIMENTAL

FeSO4

Intervention Type OTHER

reduction of phytate

Intervention Type OTHER

FeSO4 + low phytate

injera test meal 3 labeled with a 4 mg staple iron isotope tag

Group Type EXPERIMENTAL

FeSO4

Intervention Type OTHER

reduction of phytate

Intervention Type OTHER

FeSO4 + NaFeEDTA (1:1) + high phytate

injera test meal 4 labeled with a 4 mg staple iron isotope tag

Group Type EXPERIMENTAL

FeSO4

Intervention Type OTHER

NaFeEDTA

Intervention Type OTHER

FeSO4 + NaFeEDTA (1:3) + high phytate

injera test meal 5 labeled with a 4 mg staple iron isotope tag

Group Type EXPERIMENTAL

FeSO4

Intervention Type OTHER

NaFeEDTA

Intervention Type OTHER

Interventions

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FeSO4

Intervention Type OTHER

reduction of phytate

Intervention Type OTHER

NaFeEDTA

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ETH Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EK2012N31

Identifier Type: -

Identifier Source: org_study_id