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

Primary Purpose

Hypovitaminosis D, Cardiovascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
vitamin D3
25(OH) D3
Control
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypovitaminosis D focused on measuring vitamin D3, 25(OH)D3, vitamin D status, risk factors of cardiovascular diease

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

breakfast rich in vitamin D3

breakfast rich in 25(OH) D3

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline in the concentrations of vitamin D3, 25(OH)D3, 1, 25(OH)2D3 of the blood
Change from baseline in the concentrations of vitamin D3 and 25(OH)D3 of the chylomicron

Secondary Outcome Measures

change from baseline in vascular reactivity measured by Endo-PAT
change from baseline in vascular reactivity measured by digital volume pulse (DVP)
change from baseline in plasma lipids (primarily triacylglycerol, apolipoprotein B, apolipoprotein B-48, apolipoprotien B-100, total-cholesterol, HDL-cholesterol, non-esterified fatty acids)
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)
change from baseline in nitric oxide
change from baseline in inflammatory markers (tumor necrosis factor alpha, C-reactive protein and interleukin 6) of the blood
change from baseline in blood pressure
change from baseline in cognitive test
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."

Full Information

First Posted
July 28, 2015
Last Updated
September 23, 2015
Sponsor
University of Reading
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1. Study Identification

Unique Protocol Identification Number
NCT02535910
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovitaminosis D, Cardiovascular Diseases
Keywords
vitamin D3, 25(OH)D3, vitamin D status, risk factors of cardiovascular diease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
breakfast rich in vitamin D3
Arm Type
Experimental
Arm Description
subjects are asked to consume a breakfast with (20µg) vitamin D3 fortified milk and butter
Arm Title
breakfast rich in 25(OH) D3
Arm Type
Experimental
Arm Description
subjects are asked to consume a breakfast with (20µg) 25(OH) D3 fortified milk and butter
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
subjects are asked to consume a normal milk and butter (no vitamin D is added) in the breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
Subjects are asked to consume a breakfast rich in 20 µg vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
25(OH) D3
Other Intervention Name(s)
calcifediol
Intervention Description
Subjects are asked to consume a breakfast rich in 20 µg 25(OH)D3
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Subjects are asked to consume a breakfast without vitamin D
Primary Outcome Measure Information:
Title
Change from baseline in the concentrations of vitamin D3, 25(OH)D3, 1, 25(OH)2D3 of the blood
Time Frame
Acute study: measured at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour
Title
Change from baseline in the concentrations of vitamin D3 and 25(OH)D3 of the chylomicron
Time Frame
Acute study: measured at 0 (baseline), 3, 6, 8 hour
Secondary Outcome Measure Information:
Title
change from baseline in vascular reactivity measured by Endo-PAT
Time Frame
Acute study: measured at 0 (baseline) and the 24 hour
Title
change from baseline in vascular reactivity measured by digital volume pulse (DVP)
Time Frame
Acute study: measured at 0 (baseline), 120, 240, 360, 480 min and 24 hour
Title
change from baseline in plasma lipids (primarily triacylglycerol, apolipoprotein B, apolipoprotein B-48, apolipoprotien B-100, total-cholesterol, HDL-cholesterol, non-esterified fatty acids)
Description
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)
Time Frame
from 0 to 24 hour, but different measured time points for diferent lipids
Title
change from baseline in markers of insulin resistance (glucose and insulin)
Time Frame
Acute study: measured at 0, 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour
Title
change from baseline in nitric oxide
Time Frame
Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour
Title
change from baseline in inflammatory markers (tumor necrosis factor alpha, C-reactive protein and interleukin 6) of the blood
Time Frame
Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour
Title
change from baseline in blood pressure
Time Frame
Acute study: measured at 0, 120, 240, 360, 480 min and 24 hour
Title
change from baseline in cognitive test
Description
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."
Time Frame
Acute study: measured at 0, 480 min and 24 hour

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG6 6AP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28931588
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.
Results Reference
derived

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

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