Clinical trial NCT02535910: Effect of vitaminD3 or 25(OH)D3 Fortified Dairy on Vitmain D Status and CVD Risk Markers
Official title: Fortification of Milk and Butter With Either vitaminD3 or 25(OH)D3: The Effect on Vitamin D Status and Cardiovascular Disease Risk Markers in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypovitaminosis D
Cardiovascular Diseases
Keywords: vitamin D3
25(OH)D3
vitamin D status
risk factors of cardiovascular diease
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2015-08-31
Enrollment: 18
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the concentrations of vitamin D3, 25(OH)D3, 1, 25(OH)2D3 of the blood
timeFrame: Acute study: measured at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour
measure: Change from baseline in the concentrations of vitamin D3 and 25(OH)D3 of the chylomicron
timeFrame: Acute study: measured at 0 (baseline), 3, 6, 8 hour
Secondary outcomes:
measure: change from baseline in vascular reactivity measured by Endo-PAT
timeFrame: Acute study: measured at 0 (baseline) and the 24 hour
measure: change from baseline in vascular reactivity measured by digital volume pulse (DVP)
timeFrame: Acute study: measured at 0 (baseline), 120, 240, 360, 480 min and 24 hour
measure: change from baseline in plasma lipids (primarily triacylglycerol, apolipoprotein B, apolipoprotein B-48, apolipoprotien B-100, total-cholesterol, HDL-cholesterol, non-esterified fatty acids)
timeFrame: from 0 to 24 hour, but different measured time points for diferent lipids
measure: change from baseline in markers of insulin resistance (glucose and insulin)
timeFrame: Acute study: measured at 0, 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour
measure: change from baseline in nitric oxide
timeFrame: Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour
measure: change from baseline in inflammatory markers (tumor necrosis factor alpha, C-reactive protein and interleukin 6) of the blood
timeFrame: Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour
measure: change from baseline in blood pressure
timeFrame: Acute study: measured at 0, 120, 240, 360, 480 min and 24 hour
measure: change from baseline in cognitive test
timeFrame: Acute study: measured at 0, 480 min and 24 hour
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
state: Berkshire
Study officials:
References:
citation: 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.