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Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women

Primary Purpose

Iron Deficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women
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 focused on measuring Iron deficiency, Menstruating women, Vitamin D, Functional food

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Non-smoker or smokers of ≤ 3 cigarettes/day
  • Non-pregnant
  • non-breast-feeding
  • Serum ferritin <30ng/mL
  • Haemoglobin ≥11g/dL

Exclusion Criteria:

  • Amenorrhea
  • Menopause
  • Any known health problems likely to influence iron status including iron-metabolism-related diseases (iron deficiency anaemia, thalassaemia, haemochromatosis)
  • Chronic gastric diseases (inflammatory bowel disease, Crohn disease, gastric ulcers, celiac disease, hemorrhagic diseases)
  • Renal disease or allergy to some of the components of the assay diary product.
  • Blood donors
  • Have regularly consumed iron or ascorbic acid supplements within the four months prior to participating in the intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Iron-fortified dairy product

    Iron and vitamin D dairy product

    Arm Description

    Consumption of an iron-fortified flavoured skimmed milk as part of the usual diet

    Consumption of an iron and vitamin D fortified flavoured skimmed milk as part of the usual diet

    Outcomes

    Primary Outcome Measures

    Ferritin changes over 16 weeks

    Secondary Outcome Measures

    Haemoglobin changes over 16 weeks
    Total erythrocytes changes over 16 weeks
    Haematocrit changes over 16 weeks
    Mean corpuscular volume changes over 16 weeks
    Red blood cell distribution width changes over 16 weeks
    Serum iron changes over 16 weeks
    Serum transferrin changes over 16 weeks
    Transferrin saturation changes over 16 weeks
    Soluble transferrin receptor changes over 16 weeks
    25-hydroxyvitamin D changes over 16 weeks
    Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks
    Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks
    Parathormone (PTH) changes over 16 weeks
    Total cholesterol changes over 16 weeks
    LDL-cholesterol changes over 16 weeks
    HDL-cholesterol changes over 16 weeks
    Triglycerides changes over 16 weeks
    Systolic blood pressure changes over 16 weeks
    Diastolic blood pressure changes over 16 weeks
    glucose changes over 16 weeks

    Full Information

    First Posted
    November 20, 2012
    Last Updated
    June 12, 2014
    Sponsor
    National Research Council, Spain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01739907
    Brief Title
    Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Research Council, Spain

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Iron deficiency and vitamin D deficiencies are common in menstruating women. The present assay studied the influence of the consumption of a flavoured skimmed milk with iron (iron pyrophosphate) or with iron and vitamin D3 in iron deficient women on: Iron metabolism Biomarkers of bone remodelling Cardiovascular risk indexes

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron Deficiency
    Keywords
    Iron deficiency, Menstruating women, Vitamin D, Functional food

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    109 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Iron-fortified dairy product
    Arm Type
    Experimental
    Arm Description
    Consumption of an iron-fortified flavoured skimmed milk as part of the usual diet
    Arm Title
    Iron and vitamin D dairy product
    Arm Type
    Experimental
    Arm Description
    Consumption of an iron and vitamin D fortified flavoured skimmed milk as part of the usual diet
    Intervention Type
    Other
    Intervention Name(s)
    Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women
    Primary Outcome Measure Information:
    Title
    Ferritin changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
    Secondary Outcome Measure Information:
    Title
    Haemoglobin changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
    Title
    Total erythrocytes changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
    Title
    Haematocrit changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
    Title
    Mean corpuscular volume changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
    Title
    Red blood cell distribution width changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
    Title
    Serum iron changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
    Title
    Serum transferrin changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
    Title
    Transferrin saturation changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
    Title
    Soluble transferrin receptor changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 8, and 16 weeks)
    Title
    25-hydroxyvitamin D changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 8, and 16 weeks)
    Title
    Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks
    Time Frame
    16 weeks (measures at 0, 8 and 16 weeks)
    Title
    Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks
    Time Frame
    16 weeks (measures at 0, 8 and 16 weeks
    Title
    Parathormone (PTH) changes over 16 weeks
    Time Frame
    16 weeks (measures at 0, 8 and 16 weeks
    Title
    Total cholesterol changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 8 and 16 weeks
    Title
    LDL-cholesterol changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 8 and 16 weeks)
    Title
    HDL-cholesterol changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 8 and 16 weeks)
    Title
    Triglycerides changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 8 and 16 weeks)
    Title
    Systolic blood pressure changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 8 and 16 weeks)
    Title
    Diastolic blood pressure changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 8 and 16 weeks)
    Title
    glucose changes over 16 weeks
    Time Frame
    16 weeks (Measures at 0, 8 and 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: Non-smoker or smokers of ≤ 3 cigarettes/day Non-pregnant non-breast-feeding Serum ferritin <30ng/mL Haemoglobin ≥11g/dL Exclusion Criteria: Amenorrhea Menopause Any known health problems likely to influence iron status including iron-metabolism-related diseases (iron deficiency anaemia, thalassaemia, haemochromatosis) Chronic gastric diseases (inflammatory bowel disease, Crohn disease, gastric ulcers, celiac disease, hemorrhagic diseases) Renal disease or allergy to some of the components of the assay diary product. Blood donors Have regularly consumed iron or ascorbic acid supplements within the four months prior to participating in the intervention.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24663082
    Citation
    Blanco-Rojo R, Toxqui L, Lopez-Parra AM, Baeza-Richer C, Perez-Granados AM, Arroyo-Pardo E, Vaquero MP. Influence of diet, menstruation and genetic factors on iron status: a cross-sectional study in Spanish women of childbearing age. Int J Mol Sci. 2014 Mar 6;15(3):4077-87. doi: 10.3390/ijms15034077.
    Results Reference
    background
    PubMed Identifier
    23813442
    Citation
    Wright I, Blanco-Rojo R, Fernandez MC, Toxqui L, Moreno G, Perez-Granados AM, de la Piedra C, Remacha AF, Vaquero MP. Bone remodelling is reduced by recovery from iron-deficiency anaemia in premenopausal women. J Physiol Biochem. 2013 Dec;69(4):889-96. doi: 10.1007/s13105-013-0266-3. Epub 2013 Jun 28.
    Results Reference
    background
    PubMed Identifier
    24219374
    Citation
    Toxqui L, Perez-Granados AM, Blanco-Rojo R, Wright I, Gonzalez-Vizcayno C, Vaquero MP. Effects of an iron or iron and vitamin D-fortified flavored skim milk on iron metabolism: a randomized controlled double-blind trial in iron-deficient women. J Am Coll Nutr. 2013;32(5):312-20. doi: 10.1080/07315724.2013.826116.
    Results Reference
    result
    PubMed Identifier
    23771807
    Citation
    Toxqui L, Perez-Granados AM, Blanco-Rojo R, Wright I, de la Piedra C, Vaquero MP. Low iron status as a factor of increased bone resorption and effects of an iron and vitamin D-fortified skimmed milk on bone remodelling in young Spanish women. Eur J Nutr. 2014;53(2):441-8. doi: 10.1007/s00394-013-0544-4. Epub 2013 Jun 16.
    Results Reference
    result
    PubMed Identifier
    24317556
    Citation
    Toxqui L, Blanco-Rojo R, Wright I, Perez-Granados AM, Vaquero MP. Changes in blood pressure and lipid levels in young women consuming a vitamin D-fortified skimmed milk: a randomised controlled trial. Nutrients. 2013 Dec 5;5(12):4966-77. doi: 10.3390/nu5124966.
    Results Reference
    result
    PubMed Identifier
    24886470
    Citation
    Toxqui L, Perez-Granados AM, Blanco-Rojo R, Wright I, Vaquero MP. A simple and feasible questionnaire to estimate menstrual blood loss: relationship with hematological and gynecological parameters in young women. BMC Womens Health. 2014 May 30;14:71. doi: 10.1186/1472-6874-14-71.
    Results Reference
    result

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    Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women

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