Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women

Study Overview
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Brief Summary
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Iron deficiency and vitamin D deficiencies are common in menstruating women. The present assay studied the influence of the consumption of a flavoured skimmed milk with iron (iron pyrophosphate) or with iron and vitamin D3 in iron deficient women on: Iron metabolism Biomarkers of bone remodelling Cardiovascular risk indexes

Conditions
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Iron Deficiency

Intervention / Treatment
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* Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smoker or smokers of ≤ 3 cigarettes/day Non-pregnant non-breast-feeding Serum ferritin <30ng/mL Haemoglobin ≥11g/dL Exclusion Criteria: Amenorrhea Menopause Any known health problems likely to influence iron status including iron-metabolism-related diseases (iron deficiency anaemia, thalassaemia, haemochromatosis) Chronic gastric diseases (inflammatory bowel disease, Crohn disease, gastric ulcers, celiac disease, hemorrhagic diseases) Renal disease or allergy to some of the components of the assay diary product. Blood donors Have regularly consumed iron or ascorbic acid supplements within the four months prior to participating in the intervention.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron-fortified dairy product<br>Consumption of an iron-fortified flavoured skimmed milk as part of the usual diet | Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women<br> <br> |
| Experimental: Iron and vitamin D dairy product<br>Consumption of an iron and vitamin D fortified flavoured skimmed milk as part of the usual diet | Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferritin changes over 16 weeks |  | 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin changes over 16 weeks |  | 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) | 
| Total erythrocytes changes over 16 weeks |  | 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) | 
| Haematocrit changes over 16 weeks |  | 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) | 
| Mean corpuscular volume changes over 16 weeks |  | 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) | 
| Red blood cell distribution width changes over 16 weeks |  | 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) | 
| Serum iron changes over 16 weeks |  | 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) | 
| Serum transferrin changes over 16 weeks |  | 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) | 
| Transferrin saturation changes over 16 weeks |  | 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) | 
| Soluble transferrin receptor changes over 16 weeks |  | 16 weeks (Measures at 0, 8, and 16 weeks) | 
| 25-hydroxyvitamin D changes over 16 weeks |  | 16 weeks (Measures at 0, 8, and 16 weeks) | 
| Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks |  | 16 weeks (measures at 0, 8 and 16 weeks) | 
| Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks |  | 16 weeks (measures at 0, 8 and 16 weeks | 
| Parathormone (PTH) changes over 16 weeks |  | 16 weeks (measures at 0, 8 and 16 weeks | 
| Total cholesterol changes over 16 weeks |  | 16 weeks (Measures at 0, 8 and 16 weeks | 
| LDL-cholesterol changes over 16 weeks |  | 16 weeks (Measures at 0, 8 and 16 weeks) | 
| HDL-cholesterol changes over 16 weeks |  | 16 weeks (Measures at 0, 8 and 16 weeks) | 
| Triglycerides changes over 16 weeks |  | 16 weeks (Measures at 0, 8 and 16 weeks) | 
| Systolic blood pressure changes over 16 weeks |  | 16 weeks (Measures at 0, 8 and 16 weeks) | 
| Diastolic blood pressure changes over 16 weeks |  | 16 weeks (Measures at 0, 8 and 16 weeks) | 
| glucose changes over 16 weeks |  | 16 weeks (Measures at 0, 8 and 16 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron deficiency, Menstruating women, Vitamin D, Functional food