Iron Deficiency
Conditions
Keywords
Iron deficiency, Menstruating women, Vitamin D, Functional food
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
Interventions
OTHERIron fortified flavoured skimmed milk with or without vitamin D in iron deficient women
Sponsors
National Research Council, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ferritin changes over 16 weeks | 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| 25-hydroxyvitamin D changes over 16 weeks | 16 weeks (Measures at 0, 8, and 16 weeks) |
| Transferrin saturation changes over 16 weeks | 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks) |
| 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) |
| Soluble transferrin receptor 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) |
| Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks | 16 weeks (measures at 0, 8 and 16 weeks) |
Outcome results
None listed