Iron Absorption From Tef-injera in Women of Reproductive Age

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Iron Deficiency

Treatments: Other: NaFeEDTA; Other: FeSO4; Other: reduction of phytate

Study type: Interventional

Funder types: Other

Identifiers

NCT01687062

EK2012N31

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

FeSO4 + high phytate

Active Comparator group

Description:

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

Treatment:

Other: FeSO4

FeSO4 + medium phytate

Experimental group

Description:

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

Treatment:

Other: FeSO4

Other: reduction of phytate

FeSO4 + low phytate

Experimental group

Description:

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

Treatment:

Other: FeSO4

Other: reduction of phytate

FeSO4 + NaFeEDTA (1:1) + high phytate

Experimental group

Description:

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

Treatment:

Other: NaFeEDTA

Other: FeSO4

FeSO4 + NaFeEDTA (1:3) + high phytate

Experimental group

Description:

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

Treatment:

Other: NaFeEDTA

Other: FeSO4