An interventional study of Ferrous Sulfate and Aspiron in Iron Bioavailability, sponsored by Iowa State University. Completed. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by Iowa State University · Not applicable, Interventional, and Basic science
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.
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.
Iowa State University is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
The ferrous sulfate group was required to consume a test containing ferrous sulfate (10 mg of 57Fe). Participants received a meal containing 17.6 g egg albumin, 45 g corn syrup solids, 17.5 g corn oil, 6 ml vanilla extract, and 100 ml of distilled water.
Drug: Ferrous Sulfate
The Asprion group was required to follow the same protocol as the 57Fe experimental group, with the exception of taking A. Oryzae containing (8 mg natural abundace Fe and 2 mg 58Fe. Meals composition was similar to ferrous sulafte group.
Dietary Supplement: Aspiron
iron absorption
Isotope enrichment in the blood samples
Time frame: 15 days
iron status
hepcidin and ferritin
Time frame: 15 days
No study locations are listed for this record.
Plan to share: No — Publication in a journal
No publications or documents are linked to this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Iowa State University