Iron Fortified Beverages and Application in Women Predisposed to Anemia

Study Overview
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Brief Summary
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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.

Conditions
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Iron-deficiency Anemia

Intervention / Treatment
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* Dietary Supplement: non-fortified fruit juices consumed as part of the usual diet
* Dietary Supplement: Iron fortified fruit juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo juices<br>Consumption of non-iron fortified fruit juices as part of the usual diet | Dietary Supplement: non-fortified fruit juices consumed as part of the usual diet<br> <br> |
| Experimental: Iron fortified fruit juices<br>Consumption of iron fortified fruit juices as part of the usual diet | Dietary Supplement: Iron fortified fruit juice<br>* Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Ferritin |  | monitored during 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum transferrin |  | monitored during 16 weeks | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ferric pyrophosphate, Fortification, Fruit juice, Functional food, Bioavailability, iron status, Women, iron-deficiency anemia