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Completed

NCT Number: NCT01739907

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

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

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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women

Other

Primary outcomes

  1. Ferritin changes over 16 weeks

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 4, 2012
Registry last updated
Jun 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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