Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Low vitamin D levels in the blood have been shown to be associated with an increased risk of cardiovascular disease (CVD). The aim of this trial is to investigate if vitamin D2 supplements in a malted milk drink compared to placebo (malted milk drink with no vitamin D added) is associated with a change in factors that are associated with the risk of CVD.

Who can participate?
Healthy men and healthy post-menopausal women aged 50-70 years.

What does the study involve?
Participants will be randomly allocated to a placebo or to vitamin D2 provided as a malted milk drink for 3 months.

What are the possible benefits and risks of participating?
Participants screened for heart disease and diabetes risk factors. There are no expected side effects of the treatment.

Where is the study run from?
Metabolic Unit at King’s College Hospital and the Clinical Research Facility at St Thomas’ Hospital.

When is the study starting and how long is it expected to run for?
The study will have two stages; one will run from January - May 2012 and the second from January -May 2013.

Who is funding the study?
GlaxoSmithKline (GSK) Consumer Healthcare

Who is the main contact?
Prof Thomas Sanders

Trial website

Contact information



Primary contact

Prof Thomas Sanders


Contact details

King's College London
Franklin-Wilkins Building
150 Stamford Street
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The effect of low dose vitamin D2, provided in a fortified malted milk drink, on cardiovascular RISK



Study hypothesis

1. Endothelial function will be improved with vitamin D provided in a malted milk drink
2. Vitamin D will improve cardiovascular risk profile

Ethics approval

NHS Research Ethics Committee London - Westminster, 06/12/2011, ref: 11/LO/1626

Study design

Randomised placebo controlled parallel double blind study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Cardiovascular disease risk


Current interventions as of 18/02/2013:
At baseline subjects will be given sachets of a malted milk drink containing 24mcg vitamin D2, or placebo (malted milk drink without vitamin D added). They will be asked to consume 3 sachets a week for 3 months, to provide an intake equivalent to 10 mcg a day in the treatment group.

18/02/2013: Please note that this change was a correction due to an error in the original application. The intervention was 3 sachets a week for 3 months since the trial started in January 2012.

Previous interventions until 18/02/2013:
At baseline subjects will be given sachets of a malted milk drink containing 24mcg vitamin D2, or placebo (malted milk drink without vitamin D added). They will be asked to consume 3 sachets a day for 3 months, to provide an intake equivalent to 10 mcg a day in the treatment group.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Endothelial function as measured by flow mediated dilatation (FMD).

Secondary outcome measures

1. Cardiovascular risk profile (arterial stiffness measured by Pulse Wave Velocity (PWV) using a cuff on the upper arm and thigh, and Doppler probe on the neck, ambulatory blood pressure as measured by ambulatory blood pressure monitoring (ABP), fasting lipid profile, C - reactive protein as an indicator of low grade inflammation, MMP-9 and fibrinogen).
2. Markers of compliance – Ca2+ , PTH, 25(OH)D2 and 25(OH)D3 concentrations and BMI.
3. We will use the Homeostasis Model Assessment (HOMA) to estimate beta cell function and insulin sensitivity based on measurements of c-peptide and fasting glucose.
4. As it has been suggested that vitamin D supplementation suppresses renin secretion, we shall measure plasma renin concentrations.
5. We will also measure cognitive function using a series of computerised questions.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Participants will be healthy men or post-menopausal women aged between 50 and 70 years.
A fasting blood sample will be collected to determine normal liver function, blood glucose and haematology.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. A reported history of angina pectoris, myocardial infarction, stroke, peripheral vascular disease, arterial fibrillation, congenital heart defects or congenital heart disease (this will be assessed using the telephone questionnaire and confirmed with the lifestyle questionnaire completed at screening)
2. An overall risk of cardiovascular disease over the next ten years of >20% assessed according to QRISK2 (
2.Ambulatory blood pressure >150/95 mm Hg (assessed by ambulatory blood pressure monitoring)
3. Current use of medication for lowering blood cholesterol (statins) or blood pressure
4. Type 1 or Type 2 diabetes mellitus (fasting blood glucose > 7.0 mmol/L)
5. Chronic renal, liver or inflammatory bowel disease
6. Current cigarette smoker
7. Underweight or morbidly obese (Body Mass Index <18.5 and >35 kg/m2)
8. Prolonged exposure to high UV-b light since Nov 2011
9. Going to a lower latitude country, or using a tanning sunbed during the study period
10. Intolerance to study product (lactose, milk protein)
11. Taking vitamin and mineral supplements (including cod-liver oil), or prescription calcium/vitamin D
12. Unwilling to restrict consumption of oily fish to no more than 2 portions per week
13. Consuming soya milk
14. Unwilling to follow the protocol and/or give informed consent

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

King's College London
United Kingdom

Sponsor information


King's College London (UK)

Sponsor details

Franklin-Wilkins Building
Stamford Street
United Kingdom

Sponsor type




Funder type


Funder name

Biotechnology and Biological Sciences Research Council [BBSRC] (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

GlaxoSmithKline CASE Studentship ref: RH01372 (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

2014 results published in thesis []

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/07/2018: Thesis added to publication and dissemination plan. 24/05/2016: No publications found, verifying study status with principal investigator.