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

Higher Council for Scientific Research (CSIC)

Status: Completed

Conditions: Iron Deficiency

Treatments: Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women

Study type: Interventional

Funder types: Other

Identifiers

NCT01739907

AGL2009-11437

Details and patient eligibility

About

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

Enrollment: 109 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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109 participants in 2 patient groups

Iron-fortified dairy product

Experimental group

Description:

Consumption of an iron-fortified flavoured skimmed milk as part of the usual diet

Treatment:

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

Iron and vitamin D dairy product

Experimental group

Description:

Consumption of an iron and vitamin D fortified flavoured skimmed milk as part of the usual diet

Treatment:

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