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Completed

NCT Number: NCT01135576

Iron Fortified Beverages and Application in Women Predisposed to Anemia

* The objective of the study is to know if consumption of an iron fortified fruit juice containing micronized iron pyrophosphate, is useful to increase iron status in women predisposed to iron deficiency anemia. * A secondary objective is to know if consumption of this iron fortified fruit juice modifies bone remodelling.

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Key information

Conditions

Iron-deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases 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

  • Women
  • non-smoker
  • non-pregnant
  • non-breastfeeding
  • serum ferritin <40 ng/ml
  • hemoglobin>=11g/dl

Exclusion criteria

  • Serum Ferritin >=40 ng/ml
  • Hemoglobin <11g/dl
  • Amenorrhea
  • Menopause
  • Iron deficiency anemia
  • Thalassemia
  • Hemochromatosis
  • Blood donors
  • Chronic gastric diseases
  • Renal diseases
  • Eating disorders
  • Allergy to any component of the study juices
  • Consumption of iron or ascorbic acid supplements within 4 month prior to participating in the study

Treatment and study plan

non-fortified fruit juices consumed as part of the usual diet

Dietary Supplement

Iron fortified fruit juice

Dietary Supplement

Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet

Primary outcomes

  1. Serum Ferritin

    Time frame: monitored during 16 weeks

Secondary outcomes

  1. Serum transferrin

    Time frame: monitored during 16 weeks

  2. Hemoglobin

    Time frame: monitored during 16 weeks

  3. serum iron

    Time frame: monitored during 16 weeks

  4. transferrin saturation

    Time frame: monitored during 16 weeks

  5. soluble transferrin receptor

    Time frame: monitored during 16 weeks

  6. zinc protoporphyrin

    Time frame: monitored during 16 weeks

  7. Total red blood cells

    Time frame: monitored during 16 weeks

  8. Hematocrit

    Time frame: monitored during 16 weeks

  9. Mean corpuscular volume

    Time frame: monitored during 16 weeks

  10. Red blood cell distribution width

    Time frame: monitored during 16 weeks

  11. 25-hydroxycholecalciferol

    Time frame: monitored during 16 weeks

  12. alkaline phosphatase bone-isoenzyme (ALP)

    Time frame: monitored during 16 weeks

  13. serum cross-linked N-telopeptide of type I collagen (NTx)

    Time frame: monitored during 16 weeks

  14. Total cholesterol

    Time frame: monitored during 16 weeks

  15. HDL-cholesterol

    Time frame: monitored during 16 weeks

  16. LDL-cholesterol

    Time frame: monitored during 16 weeks

  17. Glucose

    Time frame: monitored during 16 weeks

  18. Serum triacylglycerols

    Time frame: monitored during 16 weeks

  19. T-chol/HDL-chol

    Time frame: monitored during 16 weeks

  20. LDL-chol/HDL-chol

    Time frame: monitored during 16 weeks

  21. Systolic blood pressure

    Time frame: monitored during 16 weeks

  22. Diastolic blood pressure

    Time frame: monitored during 16 weeks

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Grupo Leche Pascual
  • Madrid Salud
  • Ministry of Science and Innovation, Spain

Registry information

Acronym: FeDrink

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 3, 2010
Registry last updated
Dec 24, 2012

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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