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

September 23, 2015 updated by: Julie Lovegrove, University of Reading

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: Acute study: measured at 0 (baseline), 3, 6, 8 hour
Acute study: measured at 0 (baseline), 3, 6, 8 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in vascular reactivity measured by Endo-PAT
Time Frame: Acute study: measured at 0 (baseline) and the 24 hour
Acute study: measured at 0 (baseline) and the 24 hour
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
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)
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)
from 0 to 24 hour, but different measured time points for diferent lipids
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
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
Time Frame: Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour
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
Time Frame: Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour
Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour
change from baseline in blood pressure
Time Frame: Acute study: measured at 0, 120, 240, 360, 480 min and 24 hour
Acute study: measured at 0, 120, 240, 360, 480 min and 24 hour
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."
Acute study: measured at 0, 480 min and 24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 31, 2015

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITD (UAEU)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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