Iron Absorption From Tef-injera in Women of Reproductive Age

Iron Deficiency Clinical Trial

Official title:

Iron Absorption From Tef-injera in Women of Reproductive Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687062
• Other study ID #: EK2012N31
• Status: Completed
• Phase: N/A
• First received: September 13, 2012
• Last updated: October 11, 2013
• Start date: September 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Other:
• FeSO4

• reduction of phytate

• NaFeEDTA

Locations

Country	Name	City	State
Switzerland	ETH Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No