Iron-deficiency Anemia
Conditions
Keywords
Ferric pyrophosphate, Fortification, Fruit juice, Functional food, Bioavailability, iron status, Women, iron-deficiency anemia
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.
Interventions
DIETARY_SUPPLEMENTnon-fortified fruit juices consumed as part of the usual diet
DIETARY_SUPPLEMENTIron fortified fruit juice
Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet
Sponsors
Ministry of Science and Innovation, Spain
Grupo Leche Pascual
Madrid Salud, Madrid, Spain
National Research Council, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Ferritin | monitored during 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin | monitored during 16 weeks |
| serum iron | monitored during 16 weeks |
| transferrin saturation | monitored during 16 weeks |
| soluble transferrin receptor | 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 |
| Serum transferrin | 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 |
| alkaline phosphatase bone-isoenzyme (ALP) | monitored during 16 weeks |
Outcome results
None listed