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Iron Fortified Beverages and Application in Women Predisposed to Anemia (FeDrink)

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ClinicalTrials.gov Identifier: NCT01135576
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : December 24, 2012
Sponsor:
Collaborators:
Ministry of Science and Innovation, Spain
Grupo Leche Pascual
Madrid Salud, Madrid, Spain
Information provided by (Responsible Party):
M Pilar Vaquero, National Research Council, Spain

Brief Summary:
  • 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.

Condition or disease Intervention/treatment Phase
Iron-deficiency Anemia Dietary Supplement: non-fortified fruit juices consumed as part of the usual diet Dietary Supplement: Iron fortified fruit juice Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : November 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Placebo Comparator: Placebo juices
Consumption of non-iron fortified fruit juices as part of the usual diet
Dietary Supplement: non-fortified fruit juices consumed as part of the usual diet
Experimental: Iron fortified fruit juices
Consumption of iron fortified fruit juices as part of the usual diet
Dietary Supplement: Iron fortified fruit juice
Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet




Primary Outcome Measures :
  1. Serum Ferritin [ Time Frame: monitored during 16 weeks ]

Secondary Outcome Measures :
  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 ]


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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:

  • 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

Publications of Results:
Other Publications:
Navas-Carretero S, Pérez-Granados AM, Sarriá B, Schoppen S, Vaquero MP. Iron bioavailability from pate enriched with encapsulated ferric pyrophosphate or ferrous gluconate in rats. Food Sci Tech Int 13:159-163, 2007.

Responsible Party: M Pilar Vaquero, Scientific Researcher, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT01135576     History of Changes
Other Study ID Numbers: AGL2006/09519/ALI
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: December 24, 2012
Last Verified: December 2012

Keywords provided by M Pilar Vaquero, National Research Council, Spain:
Ferric pyrophosphate
Fortification
Fruit juice
Functional food
Bioavailability
iron status
Women
iron-deficiency anemia

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs