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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 28, 2010
Last Updated Date	December 21, 2012
Start Date ^ICMJE	November 2008
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 23, 2012)	Serum Ferritin [ Time Frame: monitored during 16 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 2, 2010)	Serum ferritin [ Time Frame: 16 weeks ] Serum Ferritin [ Time Frame: 0 weeks ] Serum ferritin [ Time Frame: 4 weeks ] Serum Ferritin [ Time Frame: 8 weeks ] Serum ferritin [ Time Frame: 12 weeks ]
Change History	Complete list of historical versions of study NCT01135576 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 21, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 2, 2010)	Serum transferrin [ Time Frame: 0,4,8,12,16 weeks ] Hemoglobin [ Time Frame: 0,4,8,12,16 weeks ] serum iron [ Time Frame: 0,4,8,12,16 weeks ] transferrin saturation [ Time Frame: 0,4,8,12,16 weeks ] soluble transferrin receptor [ Time Frame: 0,8,16 weeks ] zinc protoporphyrin [ Time Frame: 0,4,8,12,16 weeks ] Total red blood cells [ Time Frame: 0,4,8,12,16 weeks ] Hematocrit [ Time Frame: 0,4,8,12,16 weeks ] Mean corpuscular volume [ Time Frame: 0,4,8,12,16 weeks ] Red blood cell distribution width [ Time Frame: 0,4,8,12,16 weeks ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Iron Fortified Beverages and Application in Women Predisposed to Anemia
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Iron-deficiency Anemia
Intervention ^ICMJE	Dietary Supplement: non-fortified fruit juices consumed 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
Study Arm (s)	Placebo Comparator: Placebo juices Consumption of non-iron fortified fruit juices as part of the usual diet Intervention: 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 Intervention: Dietary Supplement: Iron fortified fruit juice
Publications *	Blanco-Rojo R, Pérez-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. 2012 May 23. [Epub ahead of print] Blanco-Rojo R, Pérez-Granados AM, Toxqui L, González-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 Feb 8;:1-9 [Epub ahead of print] Navas-Carretero S, Pérez-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. Navas-Carretero S, Pérez-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. Epub 2009 Feb 12. Navas-Carretero S, Pérez-Granados AM, Sarriá B, Vaquero MP. Iron absorption from meat pate fortified with ferric pyrophosphate in iron-deficient women. Nutrition. 2009 Jan;25(1):20-4. Epub 2008 Aug 26. Navas-Carretero S, Pérez-Granados AM, Sarriá 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. Navas-Carretero S, Sarriá B, Pérez-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. Epub 2007 Jun 18. 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. Epub 2007 Jan 5. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	122
Completion Date	May 2009
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 35 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01135576
Other Study ID Numbers ^ICMJE	AGL2006/09519/ALI
Has Data Monitoring Committee	No
Responsible Party	M Pilar Vaquero, National Research Council, Spain
Study Sponsor ^ICMJE	National Research Council, Spain
Collaborators ^ICMJE	Ministry of Science and Innovation, Spain Grupo Leche Pascual Madrid Salud, Madrid, Spain
Investigators ^ICMJE	Not Provided
Information Provided By	National Research Council, Spain
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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