Effect of vitaminD3 or 25(OH)D3 Fortified Dairy on Vitmain D Status and CVD Risk Markers

Sponsor

University of Reading (Other)

Overall Status

Unknown status

CT.gov ID

NCT02535910

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypovitaminosis D Cardiovascular Diseases	Dietary Supplement: vitamin D3 Dietary Supplement: 25(OH) D3 Dietary Supplement: Control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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 Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: breakfast rich in vitamin D3 subjects are asked to consume a breakfast with (20µg) vitamin D3 fortified milk and butter	Dietary Supplement: vitamin D3 Subjects are asked to consume a breakfast rich in 20 µg vitamin D3 Other Names: cholecalciferol
Experimental: breakfast rich in 25(OH) D3 subjects are asked to consume a breakfast with (20µg) 25(OH) D3 fortified milk and butter	Dietary Supplement: 25(OH) D3 Subjects are asked to consume a breakfast rich in 20 µg 25(OH)D3 Other Names: calcifediol
Placebo Comparator: Control subjects are asked to consume a normal milk and butter (no vitamin D is added) in the breakfast	Dietary Supplement: Control Subjects are asked to consume a breakfast without vitamin D

Arm

Intervention/Treatment

Experimental: breakfast rich in vitamin D3

subjects are asked to consume a breakfast with (20µg) vitamin D3 fortified milk and butter

Dietary Supplement: vitamin D3

Subjects are asked to consume a breakfast rich in 20 µg vitamin D3

Other Names:

cholecalciferol

Experimental: breakfast rich in 25(OH) D3

subjects are asked to consume a breakfast with (20µg) 25(OH) D3 fortified milk and butter

Dietary Supplement: 25(OH) D3

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

Other Names:

calcifediol

Placebo Comparator: Control

subjects are asked to consume a normal milk and butter (no vitamin D is added) in the breakfast

Dietary Supplement: Control

Subjects are asked to consume a breakfast without vitamin D

Outcome Measures

Primary Outcome Measures

Change from baseline in the concentrations of vitamin D3, 25(OH)D3, 1, 25(OH)2D3 of the blood [Acute study: measured at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour]
Change from baseline in the concentrations of vitamin D3 and 25(OH)D3 of the chylomicron [Acute study: measured at 0 (baseline), 3, 6, 8 hour]

Secondary Outcome Measures

change from baseline in vascular reactivity measured by Endo-PAT [Acute study: measured at 0 (baseline) and the 24 hour]
change from baseline in vascular reactivity measured by digital volume pulse (DVP) [Acute study: measured at 0 (baseline), 120, 240, 360, 480 min and 24 hour]
change from baseline in plasma lipids (primarily triacylglycerol, apolipoprotein B, apolipoprotein B-48, apolipoprotien B-100, total-cholesterol, HDL-cholesterol, non-esterified fatty acids) [from 0 to 24 hour, but different measured time points for diferent lipids]
non-esterified fatty acids, apolipoprotein B, apolipoprotein B-48, apolipoprotein B-100 are taken at 0(baseline), 60, 120, 240, 360, 480 min and 24 hour; triacylglycerol is taken at 0, 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour; total and HDL-cholesterol only be measured at 0 (baseline)
change from baseline in markers of insulin resistance (glucose and insulin) [Acute study: measured at 0, 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour]
change from baseline in nitric oxide [Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour]
change from baseline in inflammatory markers (tumor necrosis factor alpha, C-reactive protein and interleukin 6) of the blood [Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour]
change from baseline in blood pressure [Acute study: measured at 0, 120, 240, 360, 480 min and 24 hour]
change from baseline in cognitive test [Acute study: measured at 0, 480 min and 24 hour]
Trail Making Test (TMT) will be used for cognitive test, which can provides information on visual search, scanning, speed of processing, mental flexibility, and executive function. The TMT consists of two parts: TMT-A requires a participant to draw lines sequentially connecting 25 encircled numbers distributed on a computer screen, whilst in the TMT-B the participant must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). TMT-A and TMT-B will be administered using a laptop computer. Results from this two tasks reported as the number of seconds required to complete the task (completion time). The longer time spent reveal greater cognitive impairment."

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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