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

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ClinicalTrials.gov Identifier: NCT01739907
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
M Pilar Vaquero, National Research Council, Spain

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

Condition or disease Intervention/treatment Phase
Iron Deficiency Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Iron-fortified dairy product
Consumption of an iron-fortified flavoured skimmed milk as part of the usual diet
Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women
Experimental: Iron and vitamin D dairy product
Consumption of an iron and vitamin D fortified flavoured skimmed milk as part of the usual diet
Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women



Primary Outcome Measures :
  1. Ferritin changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ]

Secondary Outcome Measures :
  1. Haemoglobin changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ]
  2. Total erythrocytes changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ]
  3. Haematocrit changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ]
  4. Mean corpuscular volume changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ]
  5. Red blood cell distribution width changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ]
  6. Serum iron changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ]
  7. Serum transferrin changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ]
  8. Transferrin saturation changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ]
  9. Soluble transferrin receptor changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8, and 16 weeks) ]
  10. 25-hydroxyvitamin D changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8, and 16 weeks) ]
  11. Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks [ Time Frame: 16 weeks (measures at 0, 8 and 16 weeks) ]
  12. Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks [ Time Frame: 16 weeks (measures at 0, 8 and 16 weeks ]
  13. Parathormone (PTH) changes over 16 weeks [ Time Frame: 16 weeks (measures at 0, 8 and 16 weeks ]
  14. Total cholesterol changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks ]
  15. LDL-cholesterol changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ]
  16. HDL-cholesterol changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ]
  17. Triglycerides changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ]
  18. Systolic blood pressure changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ]
  19. Diastolic blood pressure changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ]
  20. glucose changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ]


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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:

  • 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.

Publications of Results:
Other Publications:
Responsible Party: M Pilar Vaquero, Scientific researcher, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT01739907     History of Changes
Other Study ID Numbers: AGL2009-11437
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: June 13, 2014
Last Verified: November 2012

Keywords provided by M Pilar Vaquero, National Research Council, Spain:
Iron deficiency
Menstruating women
Vitamin D
Functional food

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Iron
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Trace Elements