Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women
Not Applicable
Completed
- Conditions
- Iron Deficiency
- Interventions
- Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women
- Registration Number
- NCT01739907
- Lead Sponsor
- National Research Council, Spain
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 109
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iron-fortified dairy product Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women Consumption of an iron-fortified flavoured skimmed milk as part of the usual diet Iron and vitamin D dairy product Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women Consumption of an iron and vitamin D fortified flavoured skimmed milk as part of the usual diet
- Primary Outcome Measures
Name Time Method Ferritin changes over 16 weeks 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
- Secondary Outcome Measures
Name Time Method 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)