Clinical trial NCT01135576: Iron Fortified Beverages and Application in Women Predisposed to Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency Anemia
Keywords: Ferric pyrophosphate
Fortification
Fruit juice
Functional food
Bioavailability
iron status
Women
iron-deficiency anemia
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Science and Innovation, Spain
name: Grupo Leche Pascual
name: Madrid Salud, Madrid, Spain
First posted: 2010-06-03
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum Ferritin
timeFrame: monitored during 16 weeks
Secondary outcomes:
measure: Serum transferrin
timeFrame: monitored during 16 weeks
measure: Hemoglobin
timeFrame: monitored during 16 weeks
measure: serum iron
timeFrame: monitored during 16 weeks
measure: transferrin saturation
timeFrame: monitored during 16 weeks
measure: soluble transferrin receptor
timeFrame: monitored during 16 weeks
measure: zinc protoporphyrin
timeFrame: monitored during 16 weeks
measure: Total red blood cells
timeFrame: monitored during 16 weeks
measure: Hematocrit
timeFrame: monitored during 16 weeks
measure: Mean corpuscular volume
timeFrame: monitored during 16 weeks
measure: Red blood cell distribution width
timeFrame: monitored during 16 weeks
measure: 25-hydroxycholecalciferol
timeFrame: monitored during 16 weeks
measure: alkaline phosphatase bone-isoenzyme (ALP)
timeFrame: monitored during 16 weeks
measure: serum cross-linked N-telopeptide of type I collagen (NTx)
timeFrame: monitored during 16 weeks
measure: Total cholesterol
timeFrame: monitored during 16 weeks
measure: HDL-cholesterol
timeFrame: monitored during 16 weeks
measure: LDL-cholesterol
timeFrame: monitored during 16 weeks
measure: Glucose
timeFrame: monitored during 16 weeks
measure: Serum triacylglycerols
timeFrame: monitored during 16 weeks
measure: T-chol/HDL-chol
timeFrame: monitored during 16 weeks
measure: LDL-chol/HDL-chol
timeFrame: monitored during 16 weeks
measure: Systolic blood pressure
timeFrame: monitored during 16 weeks
measure: Diastolic blood pressure
timeFrame: monitored during 16 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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. doi: 10.1007/s00394-006-0631-x. Epub 2007 Jan 5.
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.
citation: 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.
citation: 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.
citation: 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.