Skip to main content
OpenTrials
Completed

NCT Number: NCT03156712

Iron Absorption From Iron-enriched Aspergillus Oryzae

Ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly possibly leading to higher concentrations of non-transferrin bound iron which induces oxidative stress. The objective of this study was to determine how quickly iron enters into blood stream from the iron-enriched Asperigillus oryzae (AspironTM, ASP) in contrast to ferrous sulfate. Seventeen healthy, female subjects (18-35 y) were randomized, double blind, cross-over experimental design with three treatments: 10 mg iron as FeSO4 and ASP as well as 20 mg iron as ASP.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Iowa State University

Ames, Iowa, 50011-2101, United States

About this study

In a double-blinded cross-over design, 17 research participants were randomly given one of three iron-treatments : ferrous sulfate (10mg), AspironTM (10mg), and AspironTM (20mg). Each iron treatment was given with a test meal consisting of cabbage, green peas, green beans, soy sauce, peanut oil, 40 g baby carrots, steamed rice, and orange juice. Each subject consumed a meal with one of the three iron supplements in a random order and all participants consumed the three supplements 2 weeks in between each treatment. Prior to consuming the test meal with iron supplement for each treatment, blood was collected for baseline serum iron measuremt. Following consumption of the meal with iron, subsequent blood draws were taken every 30 minutes over the time period of 4 hours to assess the incease in serum iron. Ferritin, hepcidin, iron , and c-reactive protein concentrations were measured in the serum at baselime. After two weeks other treatments were administered to each participant. The serum iron response curves for each treatment were constructed and the area under the curve (AUC) was calculated with the change of serum iron from baseline.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-pregnant
  • Non-lactating
  • Non-smoker
  • Not taking medications
  • Not taking dietary supplements (vitamins or minerals)
  • No history of gastrointestinal conditions

Exclusion criteria

  • Any history of gastrointestinal conditions
  • On medications that interfere with iron absorption
  • Unwilling to stop taking dietary supplements (vitamins or minerals)
  • Pregnant
  • Lactating
  • Smoker

Treatment and study plan

Ferrous Sulfate

Dietary Supplement

The intervention is the ASP, a natural form of iron supplement and compared to a widely used dietary iron supplement ferrous sulfate in terms of serum iron response over a 4h period.

Other names: ASP (10 mg), ASP (20 mg)

Primary outcomes

  1. Serum iron

    Time frame: 12 hours

    Area under the curve

Sponsors and collaborators

Lead sponsor

Iowa State University

Other

Registry information

Official study title

Serum Iron Increase With From Iron-enriched Aspergillus Compared to Ferrous Sulfate in Healthy Female Subjects

Acronym: BIEFS

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 17, 2017
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.