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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-10-31

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

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Detailed Description

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Conditions

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Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Iron-fortified dairy product

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Iron and vitamin D dairy product

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes