Condition category
Circulatory System
Date applied
29/08/2012
Date assigned
07/09/2012
Last edited
24/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
tom.sanders@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Sanders

ORCID ID

Contact details

King's College London
Franklin-Wilkins Building
150 Stamford Street
London
SE1 8WA
United Kingdom

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 measures

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

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

http://www.kcl.ac.uk/

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

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/05/2016: No publications found, verifying study status with principal investigator.