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 Kings 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
tom.sanders@kcl.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RH01372
Study information
Scientific title
The effect of low dose vitamin D2, provided in a fortified malted milk drink, on cardiovascular RISK
Acronym
DRISK
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular disease risk
Intervention
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
Other
Phase
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
03/01/2012
Overall trial end date
30/04/2013
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
40
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 (www.qrisk.org)
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
03/01/2012
Recruitment end date
30/04/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE1 8WA
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Franklin-Wilkins Building
Stamford Street
London
SE1 8WA
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Biotechnology and Biological Sciences Research Council [BBSRC] (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
GlaxoSmithKline CASE Studentship ref: RH01372 (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
2014 results published in thesis [https://kclpure.kcl.ac.uk/portal/files/61288715/2014_Fry_Catherine_1055698_ethesis.pdf]
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list