Iron Fortified Beverages and Application in Women Predisposed to Anemia
Information source: National Research Council, Spain
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Iron-deficiency Anemia
Intervention: non-fortified fruit juices consumed as part of the usual diet (Dietary Supplement); Iron fortified fruit juice (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: National Research Council, Spain
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Serum Ferritin
Secondary outcome: Serum transferrinHemoglobin serum iron transferrin saturation soluble transferrin receptor zinc protoporphyrin Total red blood cells Hematocrit Mean corpuscular volume Red blood cell distribution width 25-hydroxycholecalciferol alkaline phosphatase bone-isoenzyme (ALP) serum cross-linked N-telopeptide of type I collagen (NTx) Total cholesterol HDL-cholesterol LDL-cholesterol Glucose Serum triacylglycerols T-chol/HDL-chol LDL-chol/HDL-chol Systolic blood pressure Diastolic blood pressure
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Related publications: 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. doi: 10.1017/S0007114509220794. 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. doi: 10.1016/j.nut.2008.07.002. 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. 2010 May-Jun;25(3):350-65. Review. Spanish.
Starting date: November 2008
Last updated: December 21, 2012
|