Iron Absorption From Tef-injera in Women of Reproductive Age

NCT01687062 | Completed

• 1 other identifier: EK2012N31
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency

Keywords

NaFeEDTA; phytate; injera; iron absorption

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

FeSO4 + high phytate

ACTIVE COMPARATOR

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

Other: FeSO4

FeSO4 + medium phytate

EXPERIMENTAL

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

Other: FeSO4; Other: reduction of phytate

FeSO4 + low phytate

EXPERIMENTAL

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

Other: FeSO4; Other: reduction of phytate

FeSO4 + NaFeEDTA (1:1) + high phytate

EXPERIMENTAL

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

Other: FeSO4; Other: NaFeEDTA

FeSO4 + NaFeEDTA (1:3) + high phytate

EXPERIMENTAL

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

Other: FeSO4; Other: NaFeEDTA

Interventions

FeSO4 OTHER

FeSO4 + NaFeEDTA (1:1) + high phytate; FeSO4 + NaFeEDTA (1:3) + high phytate; FeSO4 + high phytate; FeSO4 + low phytate; FeSO4 + medium phytate

reduction of phytate OTHER

FeSO4 + low phytate; FeSO4 + medium phytate

NaFeEDTA OTHER

FeSO4 + NaFeEDTA (1:1) + high phytate; FeSO4 + NaFeEDTA (1:3) + high phytate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

ETH Zurich

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Fe(III)-EDTA

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 18, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2013
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

CH (1)