Iron Fortified Beverages and Application in Women Predisposed to Anemia
Not Applicable
Completed
- Conditions
- Iron-deficiency Anemia
- Interventions
- Dietary Supplement: Iron fortified fruit juiceDietary Supplement: non-fortified fruit juices consumed as part of the usual diet
- Registration Number
- NCT01135576
- Lead Sponsor
- National Research Council, Spain
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 122
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iron fortified fruit juices Iron fortified fruit juice Consumption of iron fortified fruit juices as part of the usual diet Placebo juices non-fortified fruit juices consumed as part of the usual diet Consumption of non-iron fortified fruit juices as part of the usual diet
- Primary Outcome Measures
Name Time Method Serum Ferritin monitored during 16 weeks
- Secondary Outcome Measures
Name Time Method transferrin saturation monitored during 16 weeks soluble transferrin receptor monitored during 16 weeks serum iron monitored during 16 weeks Serum transferrin monitored during 16 weeks Hemoglobin monitored during 16 weeks zinc protoporphyrin monitored during 16 weeks Total red blood cells monitored during 16 weeks Hematocrit monitored during 16 weeks Mean corpuscular volume monitored during 16 weeks Red blood cell distribution width monitored during 16 weeks 25-hydroxycholecalciferol monitored during 16 weeks alkaline phosphatase bone-isoenzyme (ALP) monitored during 16 weeks serum cross-linked N-telopeptide of type I collagen (NTx) monitored during 16 weeks Total cholesterol monitored during 16 weeks HDL-cholesterol monitored during 16 weeks LDL-cholesterol monitored during 16 weeks Glucose monitored during 16 weeks Serum triacylglycerols monitored during 16 weeks T-chol/HDL-chol monitored during 16 weeks LDL-chol/HDL-chol monitored during 16 weeks Systolic blood pressure monitored during 16 weeks Diastolic blood pressure monitored during 16 weeks