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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-05-31

Brief Summary

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This study aims to compare the acute effect of consuming milk and butter fortified with either vitamin D3 or 25 (OH) D3 on serum/plasma vitamin D status in humans. In addition, the effect of vitamin D3 or 25 (OH) D3 in milk and butter on certain CVD risk markers and cognitive function will be examined.

Detailed Description

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There is mounting evidence to show that vitamin D deficiency may increase the risk of many common and serious diseases, including osteoporosis, cardiovascular disease, some cancers and type 1 diabetes (Holick and Chen, 2008). Hypovitaminosis D is now prevalent in the UK general population. Due to diet and lifestyle changes and the use of sun block products most people do not endogenously synthesise sufficient vitamin D from sunlight exposure (Hyppönen and Power, 2007). Therefore, vitamin D intakes from dietary sources have become very important, however this is limited as there are only a few foods naturally rich in vitamin D.

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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Hypovitaminosis D Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

25(OH) D3

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

25(OH) D3

Subjects are asked to consume a breakfast rich in 20 µg 25(OH)D3

Intervention Type DIETARY_SUPPLEMENT

Control

Subjects are asked to consume a breakfast without vitamin D

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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cholecalciferol calcifediol

Eligibility Criteria

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Inclusion Criteria

* BMI: 20-35 kg/m2
* 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

* Milk allergy/intolerance or lactose intolerance
* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Julie Lovegrove

Professor Julie Lovegrove

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 28931588 (View on PubMed)

Other Identifiers

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VitD

Identifier Type: -

Identifier Source: org_study_id

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