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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01135576
Other study ID # AGL2006/09519/ALI
Secondary ID
Status Completed
Phase N/A
First received May 28, 2010
Last updated December 21, 2012
Start date November 2008
Est. completion date May 2009

Study information

Verified date December 2012
Source National Research Council, Spain
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica, Hospital Puerta de Hierro
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date May 2009
Est. primary completion date January 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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

Study Design

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


Intervention

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

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

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
National Research Council, Spain Grupo Leche Pascual, Madrid Salud, Madrid, Spain, Ministry of Science and Innovation, Spain

References & Publications (10)

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 N — View Citation

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. 2013 Mar;52(2):695-703. — View Citation

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. — View Citation

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.

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. doi: 10.1016/j.nut.2008.07.002. Epub 2008 Aug 26. — View Citation

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. — View Citation

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. doi: 10.1017/S0007114509220794. Epub 2009 Feb 12. — View Citation

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. — View Citation

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. — View Citation

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. 2010 May-Jun;25(3):350-65. Review. Spanish. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Serum Ferritin monitored during 16 weeks No
Secondary Serum transferrin monitored during 16 weeks No
Secondary Hemoglobin monitored during 16 weeks No
Secondary serum iron monitored during 16 weeks No
Secondary transferrin saturation monitored during 16 weeks No
Secondary soluble transferrin receptor monitored during 16 weeks No
Secondary zinc protoporphyrin monitored during 16 weeks No
Secondary Total red blood cells monitored during 16 weeks No
Secondary Hematocrit monitored during 16 weeks No
Secondary Mean corpuscular volume monitored during 16 weeks No
Secondary Red blood cell distribution width monitored during 16 weeks No
Secondary 25-hydroxycholecalciferol monitored during 16 weeks No
Secondary alkaline phosphatase bone-isoenzyme (ALP) monitored during 16 weeks No
Secondary serum cross-linked N-telopeptide of type I collagen (NTx) monitored during 16 weeks No
Secondary Total cholesterol monitored during 16 weeks No
Secondary HDL-cholesterol monitored during 16 weeks No
Secondary LDL-cholesterol monitored during 16 weeks No
Secondary Glucose monitored during 16 weeks No
Secondary Serum triacylglycerols monitored during 16 weeks No
Secondary T-chol/HDL-chol monitored during 16 weeks No
Secondary LDL-chol/HDL-chol monitored during 16 weeks No
Secondary Systolic blood pressure monitored during 16 weeks No
Secondary Diastolic blood pressure monitored during 16 weeks No
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