Study Results
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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COMPLETED
NA
52 participants
INTERVENTIONAL
2014-09-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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Treatment 1
500ml fortified milk (10µg vitamin D3) +1 supplement capsule (10µg vitamin D3) daily for 24 weeks
Fortified milk (10µg vitamin D3)
10µg vitamin D3 supplement
Treatment 2
500ml fortified milk (10µg vitamin D3) +1 supplement capsule (placebo) daily for 24 weeks
Fortified milk (10µg vitamin D3)
Placebo supplement
Treatment 3
500ml unfortified milk (placebo) +1 supplement capsule (10µg vitamin D3) daily for 24 weeks
Unfortified milk (placebo)
10µg vitamin D3 supplement
Treatment 4
500ml unfortified milk (placebo) +1 supplement capsule (placebo) daily for 24 weeks
Unfortified milk (placebo)
Placebo supplement
Interventions
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Fortified milk (10µg vitamin D3)
Unfortified milk (placebo)
10µg vitamin D3 supplement
Placebo supplement
Eligibility Criteria
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Inclusion Criteria
* Apparently healthy
* Living on the island of Ireland
Exclusion Criteria
* Not living on the island of Ireland
* Pregnant or lactating women and those planning to become pregnant
* Individuals who have been taking a vitamin D or calcium containing supplement in the previous three months
* Those with food intolerances or allergies that would affect their ability to consume study milk
* Individuals following a diet which excludes milk (e.g. vegans)
* Those with a diagnosed chronic medical condition or on prescribed medication known to effect vitamin D metabolism
* Those who are planning a sun holiday during the winter months (Oct-Mar)
* Adults with learning, or any other difficulties that would prevent them from completing the study protocol
20 Years
40 Years
ALL
Yes
Sponsors
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Dairy Council for Northern Ireland
OTHER
Agri-Food and Biosciences Institute
OTHER
Center for Nutrition and Health, RIVM (The Netherlands)
UNKNOWN
University of Ulster
OTHER
Responsible Party
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Locations
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Human Intervention Studies Unit
Coleraine, , United Kingdom
Countries
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Other Identifiers
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13/NI/0091
Identifier Type: -
Identifier Source: org_study_id
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