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Hypovitaminosis DNCT02535910

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

A study testing vitamin D3 and 25(OH) D3 in people with Hypovitaminosis D and Cardiovascular Diseases, run by University of Reading at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Hypovitaminosis D, Cardiovascular Diseases
What is being tested?
vitamin D3 and 25(OH) D3
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2015to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

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

    Reading, Berkshire, RG6 6AP

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
vitamin D3, 25(OH) D3, Control
Keywords
vitamin D3, 25(OH)D3, vitamin D status, risk factors of cardiovascular diease
Medical subject headings
Vitamin D Deficiency, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vitamin D3Dietary supplement

    Also called cholecalciferol

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

  • 25(OH) D3Dietary supplement

    Also called calcifediol

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

  • ControlDietary supplement

    Subjects are asked to consume a breakfast without vitamin D

Study groups in NCT02535910
Study groupRoleWhat they receive
breakfast rich in vitamin D3Experimentalsubjects are asked to consume a breakfast with (20µg) vitamin D3 fortified milk and butter
Receives: Dietary Supplement: vitamin D3
breakfast rich in 25(OH) D3Experimentalsubjects are asked to consume a breakfast with (20µg) 25(OH) D3 fortified milk and butter
Receives: Dietary Supplement: 25(OH) D3
ControlPlacebo comparatorsubjects are asked to consume a normal milk and butter (no vitamin D is added) in the breakfast
Receives: Dietary Supplement: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: Acute study: measured at 0 (baseline), 3, 6, 8 hour

Secondary outcomes (8)

  1. change from baseline in vascular reactivity measured by Endo-PAT

    Measured: Acute study: measured at 0 (baseline) and the 24 hour

  2. change from baseline in vascular reactivity measured by digital volume pulse (DVP)

    Measured: 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)

    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)

    Measured: from 0 to 24 hour, but different measured time points for diferent lipids

  4. change from baseline in markers of insulin resistance (glucose and insulin)

    Measured: 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

    Measured: 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

    Measured: Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour

  7. change from baseline in blood pressure

    Measured: Acute study: measured at 0, 120, 240, 360, 480 min and 24 hour

  8. 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."

    Measured: Acute study: measured at 0, 480 min and 24 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2015 (estimated)
  4. Study completionMay 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02535910
Sponsor's protocol ID
VitD
Status last verified
Sep 2015
First submitted
28 Jul 2015
Last updated
24 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28931588

Questions about this trial

What is this clinical trial studying?

A study testing vitamin D3 and 25(OH) D3 in people with Hypovitaminosis D and Cardiovascular Diseases, run by University of Reading at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02535910, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.

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