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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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ClinicalTrials.gov Identifier: NCT02535910
Recruitment Status : Unknown
Verified September 2015 by Julie Lovegrove, University of Reading.
Recruitment status was:  Enrolling by invitation
First Posted : August 31, 2015
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: 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 Name: 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 Name: 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




Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. change from baseline in vascular reactivity measured by Endo-PAT [ Time Frame: Acute study: measured at 0 (baseline) and the 24 hour ]
  2. 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 ]
  3. change from baseline in plasma lipids (primarily triacylglycerol, apolipoprotein B, apolipoprotein B-48, apolipoprotien B-100, total-cholesterol, HDL-cholesterol, non-esterified fatty acids) [ Time Frame: 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)

  4. 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 ]
  5. change from baseline in nitric oxide [ Time Frame: Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour ]
  6. 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 ]
  7. change from baseline in blood pressure [ Time Frame: Acute study: measured at 0, 120, 240, 360, 480 min and 24 hour ]
  8. change from baseline in cognitive test [ Time Frame: 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."



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02535910


Locations
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United Kingdom
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julie Lovegrove, Professor Julie Lovegrove, University of Reading
ClinicalTrials.gov Identifier: NCT02535910     History of Changes
Other Study ID Numbers: VitD
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by Julie Lovegrove, University of Reading:
vitamin D3
25(OH)D3
vitamin D status
risk factors of cardiovascular diease

Additional relevant MeSH terms:
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Rickets
Avitaminosis
Vitamin D Deficiency
Cardiovascular Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents