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Iron Fortified Beverages and Application in Women Predisposed to Anemia (FeDrink)

Primary Purpose

Iron-deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
non-fortified fruit juices consumed as part of the usual diet
Iron fortified fruit juice
Sponsored by
National Research Council, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron-deficiency Anemia focused on measuring Ferric pyrophosphate, Fortification, Fruit juice, Functional food, Bioavailability, iron status, Women, iron-deficiency anemia

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women
  • non-smoker
  • non-pregnant
  • non-breastfeeding
  • serum ferritin <40 ng/ml
  • hemoglobin>=11g/dl

Exclusion Criteria:

  • Serum Ferritin >=40 ng/ml
  • Hemoglobin <11g/dl
  • Amenorrhea
  • Menopause
  • Iron deficiency anemia
  • Thalassemia
  • Hemochromatosis
  • Blood donors
  • Chronic gastric diseases
  • Renal diseases
  • Eating disorders
  • Allergy to any component of the study juices
  • Consumption of iron or ascorbic acid supplements within 4 month prior to participating in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo juices

    Iron fortified fruit juices

    Arm Description

    Consumption of non-iron fortified fruit juices as part of the usual diet

    Consumption of iron fortified fruit juices as part of the usual diet

    Outcomes

    Primary Outcome Measures

    Serum Ferritin

    Secondary Outcome Measures

    Serum transferrin
    Hemoglobin
    serum iron
    transferrin saturation
    soluble transferrin receptor
    zinc protoporphyrin
    Total red blood cells
    Hematocrit
    Mean corpuscular volume
    Red blood cell distribution width
    25-hydroxycholecalciferol
    alkaline phosphatase bone-isoenzyme (ALP)
    serum cross-linked N-telopeptide of type I collagen (NTx)
    Total cholesterol
    HDL-cholesterol
    LDL-cholesterol
    Glucose
    Serum triacylglycerols
    T-chol/HDL-chol
    LDL-chol/HDL-chol
    Systolic blood pressure
    Diastolic blood pressure

    Full Information

    First Posted
    May 28, 2010
    Last Updated
    December 21, 2012
    Sponsor
    National Research Council, Spain
    Collaborators
    Ministry of Science and Innovation, Spain, Grupo Leche Pascual, Madrid Salud, Madrid, Spain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01135576
    Brief Title
    Iron Fortified Beverages and Application in Women Predisposed to Anemia
    Acronym
    FeDrink
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    May 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Research Council, Spain
    Collaborators
    Ministry of Science and Innovation, Spain, Grupo Leche Pascual, Madrid Salud, Madrid, Spain

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of the study is to know if consumption of an iron fortified fruit juice containing micronized iron pyrophosphate, is useful to increase iron status in women predisposed to iron deficiency anemia. A secondary objective is to know if consumption of this iron fortified fruit juice modifies bone remodelling.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron-deficiency Anemia
    Keywords
    Ferric pyrophosphate, Fortification, Fruit juice, Functional food, Bioavailability, iron status, Women, iron-deficiency anemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    122 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo juices
    Arm Type
    Placebo Comparator
    Arm Description
    Consumption of non-iron fortified fruit juices as part of the usual diet
    Arm Title
    Iron fortified fruit juices
    Arm Type
    Experimental
    Arm Description
    Consumption of iron fortified fruit juices as part of the usual diet
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    non-fortified fruit juices consumed as part of the usual diet
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Iron fortified fruit juice
    Intervention Description
    Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet
    Primary Outcome Measure Information:
    Title
    Serum Ferritin
    Time Frame
    monitored during 16 weeks
    Secondary Outcome Measure Information:
    Title
    Serum transferrin
    Time Frame
    monitored during 16 weeks
    Title
    Hemoglobin
    Time Frame
    monitored during 16 weeks
    Title
    serum iron
    Time Frame
    monitored during 16 weeks
    Title
    transferrin saturation
    Time Frame
    monitored during 16 weeks
    Title
    soluble transferrin receptor
    Time Frame
    monitored during 16 weeks
    Title
    zinc protoporphyrin
    Time Frame
    monitored during 16 weeks
    Title
    Total red blood cells
    Time Frame
    monitored during 16 weeks
    Title
    Hematocrit
    Time Frame
    monitored during 16 weeks
    Title
    Mean corpuscular volume
    Time Frame
    monitored during 16 weeks
    Title
    Red blood cell distribution width
    Time Frame
    monitored during 16 weeks
    Title
    25-hydroxycholecalciferol
    Time Frame
    monitored during 16 weeks
    Title
    alkaline phosphatase bone-isoenzyme (ALP)
    Time Frame
    monitored during 16 weeks
    Title
    serum cross-linked N-telopeptide of type I collagen (NTx)
    Time Frame
    monitored during 16 weeks
    Title
    Total cholesterol
    Time Frame
    monitored during 16 weeks
    Title
    HDL-cholesterol
    Time Frame
    monitored during 16 weeks
    Title
    LDL-cholesterol
    Time Frame
    monitored during 16 weeks
    Title
    Glucose
    Time Frame
    monitored during 16 weeks
    Title
    Serum triacylglycerols
    Time Frame
    monitored during 16 weeks
    Title
    T-chol/HDL-chol
    Time Frame
    monitored during 16 weeks
    Title
    LDL-chol/HDL-chol
    Time Frame
    monitored during 16 weeks
    Title
    Systolic blood pressure
    Time Frame
    monitored during 16 weeks
    Title
    Diastolic blood pressure
    Time Frame
    monitored during 16 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women non-smoker non-pregnant non-breastfeeding serum ferritin <40 ng/ml hemoglobin>=11g/dl Exclusion Criteria: Serum Ferritin >=40 ng/ml Hemoglobin <11g/dl Amenorrhea Menopause Iron deficiency anemia Thalassemia Hemochromatosis Blood donors Chronic gastric diseases Renal diseases Eating disorders Allergy to any component of the study juices Consumption of iron or ascorbic acid supplements within 4 month prior to participating in the study

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19886395
    Citation
    Navas-Carretero S, Perez-Granados AM, Schoppen S, Sarria B, Carbajal A, Vaquero MP. Iron status biomarkers in iron deficient women consuming oily fish versus red meat diet. J Physiol Biochem. 2009 Jun;65(2):165-74. doi: 10.1007/BF03179067.
    Results Reference
    background
    PubMed Identifier
    19210857
    Citation
    Navas-Carretero S, Perez-Granados AM, Schoppen S, Vaquero MP. An oily fish diet increases insulin sensitivity compared to a red meat diet in young iron-deficient women. Br J Nutr. 2009 Aug;102(4):546-53. doi: 10.1017/S0007114509220794. Epub 2009 Feb 12.
    Results Reference
    background
    PubMed Identifier
    18752926
    Citation
    Navas-Carretero S, Perez-Granados AM, Sarria B, Vaquero MP. Iron absorption from meat pate fortified with ferric pyrophosphate in iron-deficient women. Nutrition. 2009 Jan;25(1):20-4. doi: 10.1016/j.nut.2008.07.002. Epub 2008 Aug 26.
    Results Reference
    background
    PubMed Identifier
    18460487
    Citation
    Navas-Carretero S, Perez-Granados AM, Sarria B, Carbajal A, Pedrosa MM, Roe MA, Fairweather-Tait SJ, Vaquero MP. Oily fish increases iron bioavailability of a phytate rich meal in young iron deficient women. J Am Coll Nutr. 2008 Feb;27(1):96-101. doi: 10.1080/07315724.2008.10719680.
    Results Reference
    background
    PubMed Identifier
    17587790
    Citation
    Navas-Carretero S, Sarria B, Perez-Granados AM, Schoppen S, Izquierdo-Pulido M, Vaquero MP. A comparative study of iron bioavailability from cocoa supplemented with ferric pyrophosphate or ferrous fumarate in rats. Ann Nutr Metab. 2007;51(3):204-7. doi: 10.1159/000104138. Epub 2007 Jun 18.
    Results Reference
    background
    PubMed Identifier
    17206377
    Citation
    Sarria B, Navas-Carretero S, Lopez-Parra AM, Perez-Granados AM, Arroyo-Pardo E, Roe MA, Teucher B, Vaquero MP, Fairweather-Tait SJ. The G277S transferrin mutation does not affect iron absorption in iron deficient women. Eur J Nutr. 2007 Feb;46(1):57-60. doi: 10.1007/s00394-006-0631-x. Epub 2007 Jan 5.
    Results Reference
    background
    Citation
    Navas-Carretero S, Pérez-Granados AM, Sarriá B, Schoppen S, Vaquero MP. Iron bioavailability from pate enriched with encapsulated ferric pyrophosphate or ferrous gluconate in rats. Food Sci Tech Int 13:159-163, 2007.
    Results Reference
    background
    PubMed Identifier
    20593115
    Citation
    Toxqui L, De Piero A, Courtois V, Bastida S, Sanchez-Muniz FJ, Vaquero MP. [Iron deficiency and overload. Implications in oxidative stress and cardiovascular health]. Nutr Hosp. 2010 May-Jun;25(3):350-65. Spanish.
    Results Reference
    background
    PubMed Identifier
    22618893
    Citation
    Blanco-Rojo R, Perez-Granados AM, Toxqui L, Zazo P, de la Piedra C, Vaquero MP. Relationship between vitamin D deficiency, bone remodelling and iron status in iron-deficient young women consuming an iron-fortified food. Eur J Nutr. 2013 Mar;52(2):695-703. doi: 10.1007/s00394-012-0375-8. Epub 2012 May 23.
    Results Reference
    result
    PubMed Identifier
    21303569
    Citation
    Blanco-Rojo R, Perez-Granados AM, Toxqui L, Gonzalez-Vizcayno C, Delgado MA, Vaquero MP. Efficacy of a microencapsulated iron pyrophosphate-fortified fruit juice: a randomised, double-blind, placebo-controlled study in Spanish iron-deficient women. Br J Nutr. 2011 Jun;105(11):1652-9. doi: 10.1017/S0007114510005490. Epub 2011 Feb 8.
    Results Reference
    result

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