Clinical Trials Directory

Trials / Completed

CompletedNCT03156725

Assessment of Iron Absorption From Aspergillus Oryzae

Iron Absorption From Iron-enriched Aspergillus Oryzae is Similar to Ferrous Sulfate

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
Iowa State University · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Accepted

Summary

The objective of this study was to compare the absorption of a new iron product, iron enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope technique.

Detailed description

Iron deficiency anemia (IDA) remains a health crisis worldwide, especially among productive age women and children. Primarily, inorganic iron salts are being used as iron supplementation to treat IDA and are added to food to improve the nutritional value of the daily diet, however side effects and/or low absorption with diets are a result, limiting the impact on IDA. Sixteen female subject, who were 18-35 years, non-pregnancy, non-anemia with marginal lower iron status (ferritin cut-off value \<30ug/L) were recruited in this study. Subjects were randomized to orally consume test meal with stable iron isotopes Fe57 (10mg) in sulfate form and Fe58 (2mg) and 8 mg natural abundance iron in Aspiron, in two visits. Blood samples were collected at baseline and two weeks to assess isotope enrichment and iron status indicators, such as hepcidin and ferritin were measured.

Conditions

Interventions

TypeNameDescription
DRUGFerrous Sulfate
DIETARY_SUPPLEMENTAspiron

Timeline

Start date
2014-05-19
Primary completion
2014-09-14
Completion
2016-06-04
First posted
2017-05-17
Last updated
2017-05-17

Source: ClinicalTrials.gov record NCT03156725. Inclusion in this directory is not an endorsement.