Iron Deficiency Clinical Trial
Official title:
Iron Absorption From Tef-injera in Women of Reproductive Age
Verified date | October 2013 |
Source | Swiss Federal Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Switzerland | ETH Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Swiss Federal Institute of Technology |
Switzerland,
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 |
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