| ISRCTN | ISRCTN45316882 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45316882 |
| Secondary identifying numbers | RH01372 |
- Submission date
- 29/08/2012
- Registration date
- 07/09/2012
- Last edited
- 07/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
King's College London
Franklin-Wilkins Building
150 Stamford Street
London
SE1 8WA
United Kingdom
Study information
| Study design | Randomised placebo controlled parallel double blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect of low dose vitamin D2, provided in a fortified malted milk drink, on cardiovascular RISK |
| Study acronym | DRISK |
| Study objectives | 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(s) | NHS Research Ethics Committee London - Westminster, 06/12/2011, ref: 11/LO/1626 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 03/01/2012 |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 41 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 03/01/2012 |
| Date of final enrolment | 30/04/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 8WA
United Kingdom
Sponsor information
University/education
Franklin-Wilkins Building
Stamford Street
London
SE1 8WA
England
United Kingdom
| Website | http://www.kcl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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] |
| IPD sharing plan |
Editorial Notes
07/08/2020: The total final enrolment was added.
04/07/2018: Thesis added to publication and dissemination plan.
24/05/2016: No publications found, verifying study status with principal investigator.
