Iron Fortified Beverages and Application in Women Predisposed to Anemia

NCT ID: NCT01135576

Last Updated: 2012-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* 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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron-deficiency Anemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ferric pyrophosphate Fortification Fruit juice Functional food Bioavailability iron status Women iron-deficiency anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo juices

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

Iron fortified fruit juices

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

Group Type EXPERIMENTAL

Iron fortified fruit juice

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIETARY_SUPPLEMENT

Iron fortified fruit juice

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Science and Innovation, Spain

OTHER_GOV

Sponsor Role collaborator

Grupo Leche Pascual

UNKNOWN

Sponsor Role collaborator

Madrid Salud, Madrid, Spain

UNKNOWN

Sponsor Role collaborator

National Research Council, Spain

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

M Pilar Vaquero

Scientific Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19886395 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19210857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18752926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18460487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17587790 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17206377 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 20593115 (View on PubMed)

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.

Reference Type RESULT
PMID: 22618893 (View on PubMed)

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.

Reference Type RESULT
PMID: 21303569 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AGL2006/09519/ALI

Identifier Type: -

Identifier Source: org_study_id