NCT01135576

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
Last Updated

December 24, 2012

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

May 28, 2010

Last Update Submit

December 21, 2012

Conditions

Iron-deficiency Anemia

Keywords

Ferric pyrophosphateFortificationFruit juiceFunctional foodBioavailabilityiron statusWomeniron-deficiency anemia

Outcome Measures

Primary Outcomes (1)

  • Serum Ferritin

    monitored during 16 weeks

Secondary Outcomes (22)

  • Serum transferrin

    monitored during 16 weeks

  • Hemoglobin

    monitored during 16 weeks

  • serum iron

    monitored during 16 weeks

  • transferrin saturation

    monitored during 16 weeks

  • soluble transferrin receptor

    monitored during 16 weeks

  • +17 more secondary outcomes

Study Arms (2)

Placebo juices

PLACEBO COMPARATOR

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

Iron fortified fruit juices

EXPERIMENTAL

Consumption of iron fortified fruit juices as part of the usual diet

Dietary Supplement: Iron fortified fruit juice

Interventions

non-fortified fruit juices consumed as part of the usual dietDIETARY_SUPPLEMENT
Placebo juices
Iron fortified fruit juiceDIETARY_SUPPLEMENT

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

Iron fortified fruit juices

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Navas-Carretero S, Perez-Granados AM, Schoppen S, Sarria B, Carbajal A, Vaquero MP. Iron status biomarkers in iron deficient women consuming oily fish versus red meat diet. J Physiol Biochem. 2009 Jun;65(2):165-74. doi: 10.1007/BF03179067.

    PMID: 19886395BACKGROUND

  • Navas-Carretero S, Perez-Granados AM, Schoppen S, Vaquero MP. An oily fish diet increases insulin sensitivity compared to a red meat diet in young iron-deficient women. Br J Nutr. 2009 Aug;102(4):546-53. doi: 10.1017/S0007114509220794. Epub 2009 Feb 12.

    PMID: 19210857BACKGROUND

  • Navas-Carretero S, Perez-Granados AM, Sarria B, Vaquero MP. Iron absorption from meat pate fortified with ferric pyrophosphate in iron-deficient women. Nutrition. 2009 Jan;25(1):20-4. doi: 10.1016/j.nut.2008.07.002. Epub 2008 Aug 26.

    PMID: 18752926BACKGROUND

  • Navas-Carretero S, Perez-Granados AM, Sarria B, Carbajal A, Pedrosa MM, Roe MA, Fairweather-Tait SJ, Vaquero MP. Oily fish increases iron bioavailability of a phytate rich meal in young iron deficient women. J Am Coll Nutr. 2008 Feb;27(1):96-101. doi: 10.1080/07315724.2008.10719680.

    PMID: 18460487BACKGROUND

  • Navas-Carretero S, Sarria B, Perez-Granados AM, Schoppen S, Izquierdo-Pulido M, Vaquero MP. A comparative study of iron bioavailability from cocoa supplemented with ferric pyrophosphate or ferrous fumarate in rats. Ann Nutr Metab. 2007;51(3):204-7. doi: 10.1159/000104138. Epub 2007 Jun 18.

    PMID: 17587790BACKGROUND

  • Sarria B, Navas-Carretero S, Lopez-Parra AM, Perez-Granados AM, Arroyo-Pardo E, Roe MA, Teucher B, Vaquero MP, Fairweather-Tait SJ. The G277S transferrin mutation does not affect iron absorption in iron deficient women. Eur J Nutr. 2007 Feb;46(1):57-60. doi: 10.1007/s00394-006-0631-x. Epub 2007 Jan 5.

    PMID: 17206377BACKGROUND

  • 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.

    BACKGROUND

  • Toxqui L, De Piero A, Courtois V, Bastida S, Sanchez-Muniz FJ, Vaquero MP. [Iron deficiency and overload. Implications in oxidative stress and cardiovascular health]. Nutr Hosp. 2010 May-Jun;25(3):350-65. Spanish.

    PMID: 20593115BACKGROUND

  • Blanco-Rojo R, Perez-Granados AM, Toxqui L, Zazo P, de la Piedra C, Vaquero MP. Relationship between vitamin D deficiency, bone remodelling and iron status in iron-deficient young women consuming an iron-fortified food. Eur J Nutr. 2013 Mar;52(2):695-703. doi: 10.1007/s00394-012-0375-8. Epub 2012 May 23.

    PMID: 22618893RESULT

  • Blanco-Rojo R, Perez-Granados AM, Toxqui L, Gonzalez-Vizcayno C, Delgado MA, Vaquero MP. Efficacy of a microencapsulated iron pyrophosphate-fortified fruit juice: a randomised, double-blind, placebo-controlled study in Spanish iron-deficient women. Br J Nutr. 2011 Jun;105(11):1652-9. doi: 10.1017/S0007114510005490. Epub 2011 Feb 8.

    PMID: 21303569RESULT

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Researcher

Study Record Dates

First Submitted

May 28, 2010

First Posted

June 3, 2010

Study Start

November 1, 2008

Primary Completion

January 1, 2009

Study Completion

May 1, 2009

Last Updated

December 24, 2012

Record last verified: 2012-12