Iron Absorption From Iron-enriched Aspergillus Oryzae

NCT03156712 | Completed

• 1 other identifier: BIEFS
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron-deficiency; Absorption; Iron; Anemia, Iron Deficiency; Bioavailability; Serum Iron

Keywords

Anemia; Iron deficiency anemia; Iron fortification; ferrous sulfate; aspergillus oryzae; iron supplementation; AUC

Outcome Measures

Primary Outcomes (1)

• Serum iron

  Area under the curve

  12 hours

Study Arms (3)

FeSO4

EXPERIMENTAL

Ferrou sulfate: Each participant was given a one time oral dose of the 10 mg iron as ferrous sulfate with the test meal (described in study design) and serum iron was measured every 30 min for 4 hours.

Dietary Supplement: Ferrous sulfate

ASP Fe (10 mg)

EXPERIMENTAL

ASP (10 mg Fe): Each participants was given a one time oral dose of ASP containing 10 mg iron. The capsule was consumed with the test meal and serum iron was measured every 30 min for 4 hours.

Dietary Supplement: Ferrous sulfate

ASP Fe (20 mg)

EXPERIMENTAL

ASP (20 mg Fe): Each participant was given a one time oral dose ASP containing of 20 mg iron The capsule was consumed with the test meal and serum iron was measured every 30 min for 4 hours.

Dietary Supplement: Ferrous sulfate

Interventions

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.

Also known as: ASP (10 mg), ASP (20 mg)

ASP Fe (10 mg); ASP Fe (20 mg); FeSO4

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Iowa State University

Ames, Iowa, 50011-2101, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Interventions

ferrous sulfate; aspartyl-aspartic acid

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Manju B Reddy, Ph.D.

  Iowa State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both investigators and participants were blinded to the iron treatment in this double-blinded, crossover study. Three different iron supplements were given, whereby participants were either administered 10 mg FeSO4, 10 mg ASP Fe, or 20 mg ASP Fe.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double-blinded, cross-over experimental design, whereby subjects were randomly given three different iron supplements with a meal in three different visits. All three visits (iron treatments) were each separated by two weeks time.

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: May 29, 2013
• Primary Completion: November 20, 2013
• Study Completion: February 13, 2014
• Last Updated: May 18, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)