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Clinical Trials/NCT01739907
NCT01739907CompletedNot Applicable

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

National Research Council, Spain0 sites109 target enrollmentStarted: January 1, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
109
Primary Endpoint
Ferritin changes over 16 weeks
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Ferritin changes over 16 weeks

Time Frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)

Secondary Outcomes

  • Haemoglobin changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
  • Total erythrocytes changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
  • Haematocrit changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
  • Mean corpuscular volume changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
  • Red blood cell distribution width changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
  • Serum iron changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
  • Serum transferrin changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
  • Transferrin saturation changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
  • Soluble transferrin receptor changes over 16 weeks(16 weeks (Measures at 0, 8, and 16 weeks))
  • 25-hydroxyvitamin D changes over 16 weeks(16 weeks (Measures at 0, 8, and 16 weeks))
  • Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks(16 weeks (measures at 0, 8 and 16 weeks))
  • Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks(16 weeks (measures at 0, 8 and 16 weeks)
  • Parathormone (PTH) changes over 16 weeks(16 weeks (measures at 0, 8 and 16 weeks)
  • Total cholesterol changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks)
  • LDL-cholesterol changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))
  • HDL-cholesterol changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))
  • Triglycerides changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))
  • Systolic blood pressure changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))
  • Diastolic blood pressure changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))
  • glucose changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))

Investigators

Sponsor
National Research Council, Spain
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

M Pilar Vaquero

Scientific researcher

National Research Council, Spain

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