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Trial record 28 of 46 for:    FERRIC SULFATE

Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology

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ClinicalTrials.gov Identifier: NCT03586245
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Manju B. Reddy, Iowa State University

Brief Summary:
The objective of this study was to compare the iron absorption from ferric pyrophosphate enriched Aspergillus oryzae (ASP-p) to commonly used ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when fortified in chicken bouillon, using stable isotope methodology.

Condition or disease Intervention/treatment Phase
Iron Absorption Dietary Supplement: Ferric pyrophosphate Dietary Supplement: Aspiron Dietary Supplement: Ferrous sulfate Not Applicable

Detailed Description:
Iron deficiency anemia (IDA) remains the most common nutrient deficiency, globally. Consequences such as decreased cognition, growth impairment, and morbidity and mortality arise from inadequate iron intake. Many technological challenges are presented in fortifying foods with iron, as inorganic iron salts are known to cause organoleptic problems in the food. As a result, finding an iron fortificant that doesn't alter taste, smell or stability of the food is ideal, however most suitable iron fortificants contain low bioavailability. Thirty-five non-anemic female subjects with ferritin ≤ 40 µg/L were recruited for both studies (17 in study I; 18 in study II). In both studies, each meal contained a total of 4.2 mg of added iron fortificants to a test meal containing 6.6 g of chicken bouillon. Participants were randomized to consume either meal A or B, followed by B or C. In study I, subjects consumed a total of 10 mg 57Fe as FePP and 2 mg 58Fe as ASP-p each over three consecutive days. Study II, subjects consumed a total of 10 mg 57Fe as FeSO4 and 2 mg 58Fe as ASP-p over 2 weekends. Blood samples collected at baseline were used to measure iron status indicators such as serum ferritin, C-reactive protein, hepcidin and hematocrit. Fourteen days following final isotope dosing, whole blood samples were collected and the fractional iron absorption of each iron fortificant containing labelled stable isotopes was measured via thermal ionization mass spectrometry with estimation of 80% incorporation into the hemoglobin.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Subjects consumed two stable isotopes (57Fe and 58Fe). Study I, three consecutive days of meal A followed by crossover of three days meal B were consumed. Study II was a crossover between meal B and meal C.
Masking: Single (Participant)
Masking Description: All stable isotopes (FePP, ASP, FeSO4) were all individually added to test meal and mixed thoroughly by investigators. Participants were brought the meal to consume, unknowingly of which respective treatment they were receiving.
Primary Purpose: Treatment
Official Title: Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Iron Isotope Methodology.
Actual Study Start Date : October 28, 2016
Actual Primary Completion Date : May 3, 2017
Actual Study Completion Date : June 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Active Comparator: Ferric pyrophosphate

Study I group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds.

  • 57FePP (95.8%) 3.49 mg
  • Aspergillus oryzae (unenriched) 0.025 mg
  • FePP natural abundance 0.685 mg.

Subjects received iron fortificants in a meal composed of zucchini, cabbage, carrot (42g each), onion (24g), corn oil (6.3 g), jasmine rice (75g dw), and flavored granulated chicken bouillon (6.6g). All meals were consumed in a fasted state with nothing to eat or drink (besides water) for 3 hours following consumption.

Dietary Supplement: Ferric pyrophosphate
57 Iron isotopically labeled FePP powder.

Experimental: Aspiron

The Aspiron group was required to follow the same protocol as the 57Fe as FePP, with the exception of consuming 58Fe ASP.

  • ASP-p (8% Fe; natural abundance) 3.516 mg
  • 58ASP-p (5% Fe; 99.5% enrichment) 0.68 mg
  • 4.2 total mg of Fe
Dietary Supplement: Aspiron
58 Iron isotope intrinsically labeled Aspergillus oryzae.

Ferrous sulfate

The FeSO4 study group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds. .

  • Aspergillus oryzae (unenriched) 0.027 mg
  • 57FeSO4 (95.4%) 3.18 mg
  • 4.2 total mg of Fe
Dietary Supplement: Ferrous sulfate
57 Iron isotopically labeled FeSO4 powder.




Primary Outcome Measures :
  1. Percentage Fractional Iron absorption of FePP, FeS)4 and ASP [ Time Frame: Whole blood collected 14 days following isotope consumption to allow for enrichment. ]
    Isotope enrichment in the whole blood samples after 14 days of feeding the meals assuming 80% incorporation of iron into the hemoglobin. Circulating iron was calculated from blood volume, height (cm), weight (kg) and hemoglobin (g/dL).



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Suboptimal iron stores (Serum ferritin < 40 µg/L)
  • BMI in range 18.5 - 24.9 kg/m2
  • Willing to consumed meals containing iron supplement
  • Willing to discontinue blood donation two weeks prior and during the study
  • Willing to discontinue vitamin and mineral supplement use during the study
  • Willing to provide a 15 ml blood for initial screening and 30 ml blood during the study (15 ml at each visit for 2 times in 24 days)
  • Willing to attend 8 lab visits during the study

Exclusion Criteria:

  • Pregnant
  • Lactating
  • Smoker
  • Anemic (hemoglobin < 120 g/L)
  • Has gastrointestinal disease/condition that can affect absorption
  • Vegetarian
  • Allergic to corn, wheat, soybean nor fungal supplements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586245


Sponsors and Collaborators
Iowa State University
Investigators
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Principal Investigator: Manju B Reddy, PhD Iowa State University

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Responsible Party: Dr. Manju B. Reddy, Professor, Iowa State University
ClinicalTrials.gov Identifier: NCT03586245     History of Changes
Other Study ID Numbers: ASP Study
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Publish results in a journal.

Keywords provided by Dr. Manju B. Reddy, Iowa State University:
Iron Bioavailability
Iron Fortification
ferrous sulfate
ferric pyrophosphate
aspergillus oryzae
stable isotope

Additional relevant MeSH terms:
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Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs