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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01135576
First received: May 28, 2010
Last updated: December 21, 2012
Last verified: December 2012
  Purpose
  • 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 Intervention
Iron-deficiency Anemia
Dietary Supplement: non-fortified fruit juices consumed as part of the usual diet
Dietary Supplement: Iron fortified fruit juice

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Serum Ferritin [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum transferrin [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • Hemoglobin [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • serum iron [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • transferrin saturation [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • soluble transferrin receptor [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • zinc protoporphyrin [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • Total red blood cells [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • Hematocrit [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • Mean corpuscular volume [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • Red blood cell distribution width [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • 25-hydroxycholecalciferol [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • alkaline phosphatase bone-isoenzyme (ALP) [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • serum cross-linked N-telopeptide of type I collagen (NTx) [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • LDL-cholesterol [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • Serum triacylglycerols [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • T-chol/HDL-chol [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • LDL-chol/HDL-chol [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • Systolic blood pressure [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
  • Diastolic blood pressure [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
  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:
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.
Toxqui L, De Piero A, Courtois V, Bastida S, Sánchez-Muniz FJ, Vaquero MP. Iron deficiency and overload. Implications in oxidative stress and cardiovascular health. Nutr Hosp 25:350-65, 2010.

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
Study First Received: May 28, 2010
Last Updated: December 21, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica, Hospital Puerta de Hierro

Keywords provided by 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
Deficiency Diseases
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Malnutrition
Metabolic Diseases
Nutrition Disorders
Iron
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 21, 2014