Iron Fortified Beverages and Application in Women Predisposed to Anemia

Iron-deficiency Anemia Clinical Trial

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Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135576
• Other study ID #: AGL2006/09519/ALI
• 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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron-deficiency Anemia

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