Iron Absorption From Tef-injera in Women of Reproductive Age

Study Overview
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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.

Official Title
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Iron Absorption From Tef-injera in Women of Reproductive Age

Conditions
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Iron Deficiency

Intervention / Treatment
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* Other: FeSO4
* Other: reduction of phytate
* Other: NaFeEDTA


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FeSO4 + high phytate<br>injera test meal 1 labeled with a 4 mg staple iron isotope tag | Other: FeSO4<br> <br> |
| Experimental: FeSO4 + medium phytate<br>injera test meal 2 labeled with a 4 mg staple iron isotope tag | Other: FeSO4<br> <br> Other: reduction of phytate<br> <br> |
| Experimental: FeSO4 + low phytate<br>injera test meal 3 labeled with a 4 mg staple iron isotope tag | Other: FeSO4<br> <br> Other: reduction of phytate<br> <br> |
| Experimental: FeSO4 + NaFeEDTA (1:1) + high phytate<br>injera test meal 4 labeled with a 4 mg staple iron isotope tag | Other: FeSO4<br> <br> Other: NaFeEDTA<br> <br> |
| Experimental: FeSO4 + NaFeEDTA (1:3) + high phytate<br>injera test meal 5 labeled with a 4 mg staple iron isotope tag | Other: FeSO4<br> <br> Other: NaFeEDTA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron absorption | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NaFeEDTA, phytate, injera, iron absorption