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Trial record 37 of 46 for:    FERRIC SULFATE

Iron Absorption From Rice Fortified With Ferric Pyrophosphate

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ClinicalTrials.gov Identifier: NCT02176759
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

Brief Summary:

Ferric pyrophosphate (FePP) is a water-insoluble, food grade iron compound used to fortify rice, infant cereals and chocolate-drink powders as it causes no organoleptic changes to the food vehicle. However, it is only of low absorption in man. Therefore, strategies to enhance the bioavailability of FePP, such as adding citrate or decreasing the particle size of FePP need to be investigated. The primary objectives of the present study are: 1) to test whether the presence of citrate in iron fortified rice with FePP results in higher iron bioavailability, and 2) to test whether the presence of citrate in the rice grain during the extrusion and cooking process results in higher iron bioavailability compared with iron-fortified rice where citrate has been added shortly before consumption. As a secondary objective the investigators will compare the absorption from different FePP combinations with a reference meal fortified with ferrous sulphate. The investigator hypothesize that the addition of citrate enhances iron absorption and that the positive effect is greater when the citrate is added during the extrusion.

The investigator will conduct an iron absorption study in 20 women, 18 to 45 years old to evaluate the iron bioavailability from extruded rice fortified with 1) regular FePP, 2) regular FePP and citrate (both extruded into the rice kernels), 3) regular FePP and citrate added at the time of consumption, and 4) from normal rice fortified with ferrous sulphate at the time of consumption. Iron absorption will be measured as erythrocyte incorporation of stable iron isotopes at least 14 days after the administration of the isotopically labelled test meals. The iron absorption from the different meals within the same participant will be compared by repeated-measures ANOVA followed by a Bonferroni corrected pairwise comparison.

The present study will provide important data where iron bioavailability from rice is accurately and directly measured using stable isotopic labels as absorption tracers. This direct data can be used to base decisions on the level of fortification, can potentially reduce costs and optimize iron delivery to the targeted population in iron fortification programs.


Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Iron Deficiency Anemia Other: Administration of rice fortified with regular FePP Other: Administration of rice fortified with regular FePP with citrate added during extrusion Other: Administration of rice fortified with regular FePP and citrate added at consumption Other: Administration of rice fortified with ferrous sulphate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : September 2014
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Regular FePP
Rice (50g dry weight) fortified with 4mg regular FePP
Other: Administration of rice fortified with regular FePP
Experimental: Regular FePP with citrate added during extrusion
Rice (50g dry weight) fortified with 4mg regular FePP and citrate added during the extrusion process
Other: Administration of rice fortified with regular FePP with citrate added during extrusion
Experimental: Regular FePP with citrated added at consumption
Rice (50g dry weight) fortified with 4mg regular FePP and citrate shortly added before consumption
Other: Administration of rice fortified with regular FePP and citrate added at consumption
Active Comparator: Ferrous sulphate
Rice (50g dry weight) fortified with 4mg ferrous sulphate
Other: Administration of rice fortified with ferrous sulphate



Primary Outcome Measures :
  1. Change from baseline in the isotopic ratio of iron in blood at week 2 [ Time Frame: baseline, 2 weeks ]
    The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

  2. Change from week 2 in the isotopic ratio of iron in blood at week 4 [ Time Frame: 2 weeks, 4 weeks ]
    The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

  3. Change from week 4 in the isotopic ratio of iron in blood at week 6 [ Time Frame: 4 weeks, 6 weeks ]
    The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female, 18 to 45 years old
  • Normal body Mass Index (18.5 - 25 kg/m2)
  • Body weight < 65 kg
  • Signed informed consent

Exclusion Criteria:

  • Pregnancy (assessed by a pregnancy test)
  • Lactating
  • Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
  • Continuous/long-term use of medication during the whole study (except for contraceptives)
  • Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
  • Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
  • Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days
  • Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments)

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): NCT02176759


Locations
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Switzerland
Human Nutrition Laboratory
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT02176759     History of Changes
Other Study ID Numbers: Rice_SFePP
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action