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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M Pilar Vaquero, National Research Council, Spain
ClinicalTrials.gov Identifier:
NCT01739907
First received: November 20, 2012
Last updated: June 12, 2014
Last verified: November 2012
  Purpose

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 Intervention
Iron Deficiency
Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Research Council, Spain:

Primary Outcome Measures:
  • Ferritin changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Haemoglobin changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ] [ Designated as safety issue: No ]
  • Total erythrocytes changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ] [ Designated as safety issue: No ]
  • Haematocrit changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ] [ Designated as safety issue: No ]
  • Mean corpuscular volume changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ] [ Designated as safety issue: No ]
  • Red blood cell distribution width changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ] [ Designated as safety issue: No ]
  • Serum iron changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ] [ Designated as safety issue: No ]
  • Serum transferrin changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ] [ Designated as safety issue: No ]
  • Transferrin saturation changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) ] [ Designated as safety issue: No ]
  • Soluble transferrin receptor changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8, and 16 weeks) ] [ Designated as safety issue: No ]
  • 25-hydroxyvitamin D changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8, and 16 weeks) ] [ Designated as safety issue: No ]
  • Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks [ Time Frame: 16 weeks (measures at 0, 8 and 16 weeks) ] [ Designated as safety issue: No ]
  • Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks [ Time Frame: 16 weeks (measures at 0, 8 and 16 weeks ] [ Designated as safety issue: No ]
  • Parathormone (PTH) changes over 16 weeks [ Time Frame: 16 weeks (measures at 0, 8 and 16 weeks ] [ Designated as safety issue: No ]
  • Total cholesterol changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks ] [ Designated as safety issue: No ]
  • LDL-cholesterol changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ] [ Designated as safety issue: No ]
  • HDL-cholesterol changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ] [ Designated as safety issue: No ]
  • Triglycerides changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ] [ Designated as safety issue: No ]
  • Systolic blood pressure changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ] [ Designated as safety issue: No ]
  • Diastolic blood pressure changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ] [ Designated as safety issue: No ]
  • glucose changes over 16 weeks [ Time Frame: 16 weeks (Measures at 0, 8 and 16 weeks) ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

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
Study First Received: November 20, 2012
Last Updated: June 12, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

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

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

ClinicalTrials.gov processed this record on October 22, 2014