Effect of vitaminD3 or 25(OH)D3 Fortified Dairy on Vitmain D Status and CVD Risk Markers
NCT ID: NCT02535910
Last Updated: 2015-09-24
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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UNKNOWN
NA
18 participants
INTERVENTIONAL
2015-08-31
2016-05-31
Brief Summary
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Detailed Description
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Some countries (e.g. USA, Canada) fortify milk with vitamin D which results in milk being the major contributor to vitamin D intake. Vitamin D3 is the most common form used for the fortification of currently fortified foods. However, there is now some evidence that 25(OH)D3 can increase vitamin D status of humans more effectively than vitamin D3 (Bischoff-Ferrari et al, 2012; Cashman et al, 2012). To our knowledge, very few human intervention studies have compared the efficacy of 25(OH)D3 versus vitamin D3 to increase vitamin D status, and there has been no acute human study to examine the effect of the both forms of vitamin D fortified dairy products on vitamin D status in humans.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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breakfast rich in vitamin D3
subjects are asked to consume a breakfast with (20µg) vitamin D3 fortified milk and butter
vitamin D3
Subjects are asked to consume a breakfast rich in 20 µg vitamin D3
breakfast rich in 25(OH) D3
subjects are asked to consume a breakfast with (20µg) 25(OH) D3 fortified milk and butter
25(OH) D3
Subjects are asked to consume a breakfast rich in 20 µg 25(OH)D3
Control
subjects are asked to consume a normal milk and butter (no vitamin D is added) in the breakfast
Control
Subjects are asked to consume a breakfast without vitamin D
Interventions
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vitamin D3
Subjects are asked to consume a breakfast rich in 20 µg vitamin D3
25(OH) D3
Subjects are asked to consume a breakfast rich in 20 µg 25(OH)D3
Control
Subjects are asked to consume a breakfast without vitamin D
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Glucose \<7 mmol/l (not diagnosed with diabetes)
* Total cholesterol \<7 mmol/l
* TAG \<4 mmol/l
* Serum 25(OH)D3 ≤50 nmol/L
* Normal liver and kidney function
* Haemoglobin: adult male \>125 g/L
Exclusion Criteria
* Cardiovascular, renal, gastrointestinal, respiratory, endocrine disease or cancer
* Use of nutritional supplements, particularly those containing vitamin D
* Outdoor workers and use of tanning beds
* Overseas holidays two months before or during study period
30 Years
65 Years
MALE
Yes
Sponsors
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University of Reading
OTHER
Responsible Party
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Julie Lovegrove
Professor Julie Lovegrove
Locations
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Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, United Kingdom
Countries
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References
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Guo J, Jackson KG, Che Taha CSB, Li Y, Givens DI, Lovegrove JA. A 25-Hydroxycholecalciferol-Fortified Dairy Drink Is More Effective at Raising a Marker of Postprandial Vitamin D Status than Cholecalciferol in Men with Suboptimal Vitamin D Status. J Nutr. 2017 Nov;147(11):2076-2082. doi: 10.3945/jn.117.254789. Epub 2017 Sep 20.
Other Identifiers
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VitD
Identifier Type: -
Identifier Source: org_study_id
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