Condition category
Circulatory System
Date applied
05/01/2009
Date assigned
30/01/2009
Last edited
21/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Small studies have shown that vitamin D, a hormone that the skin usually makes using sunshine, may be able to reduce blood pressure in some people. The majority of people in Scotland have low levels of vitamin D, and people with low vitamin D have a higher chance of a heart attack. People who have had a heart attack have blood vessels that do not work as well as normal, and this leads to a higher risk of future heart problems.
The aim of this study is to find out if giving extra vitamin D to people who have had a heart attack helps to improve the function of blood vessels. It also aims to investigate whether giving vitamin D can reduce blood pressure and cholesterol in people who have had a heart attack.

Who can participate?
Adults >18 years who have had a heart attack

What does the study involve?
The study lasts for six months. Participants are randomly allocated to one of two groups, and given either a teaspoon of the vitamin D oil or a placebo (dummy) oil at the start of the study, two months later, and two months after that.
The participants are seen at the start, and at 2, 4 and 6 months later. Each visit will last an hour to 1 1/2 hours. At each visit, they will receive some or all of the following depending on which visit it is:
- Blood pressure taken
- Blood sample taken
- Heart tracing (ECG)
- The function of the arteries in the fingers is measured. The participant lies down and has a thimble-like device attached to one finger on each hand. This measures blood flow in the fingertips. After 5 minutes, a blood pressure cuff is inflated on one arm and kept blown up for 5 minutes. After this, the cuff is let down and the blood flow in the fingertips is measured for another 5 minutes. No needles are used in this test.

What are the possible benefits and risks of participating?
Although this dose of vitamin D has been used before and is known to be safe there is a small possibility of side effects. The participant is closely monitored for side effects caused by high calcium levels: sickness, diarrhoea, thirst or dizziness. To reduce the chance of vitamin D increasing the calcium levels in their blood, they are asked not to take vitamin D supplements or calcium supplements whilst taking part in this study. Having blood taken can cause some bruising. The blood pressure cuff causes mild discomfort to some people.

Where is the study run from?
Ninewells Hospital Dundee (UK)

When is the study starting and how long is it expected to run for?
September 2008 to August 2011

Who is funding the study?
Chest Heart and Stroke Scotland (UK)

Who is the main contact?
Dr Miles Witham (Scientific)
m.witham@dundee.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Miles Witham

ORCID ID

Contact details

Section of Ageing and Health
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632436
m.witham@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2008CV05

Study information

Scientific title

Effects of vitamin D supplementation on markers of vascular function after myocardial infarction: a placebo controlled, double blind, parallel group, randomised controlled trial

Acronym

DAMI

Study hypothesis

Vitamin D3 supplementation will lead to improvements in vascular function, and reduce markers of thrombosis, inflammation and platelet activation that are known to be deranged in the period following myocardial infarction and that are thought to contribute to the high risk of further vascular events.

Ethics approval

Fife and Forth Valley Research Ethics Committee, 24/06/2009, ref: 09/S0501/53

Study design

Placebo-controlled double-blind parallel group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Myocardial infarction

Intervention

100,000 units of oral vitamin D or placebo at 0, 2 and 4 months. Total follow up is 6 months per patient.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin D

Primary outcome measure

Current primary outcome measure (as of 21/02/2018):
Change in endothelial function measured using the EndoPAT finger plethysmography system between baseline and 6 months

Previous primary outcome measure:
Change in endothelial function between baseline and 6 months.

Secondary outcome measures

Current secondary outcome measures (as of 21/02/2018):
1. Change in blood pressure measured using OMRON HEP 705 oscillometric automated machine at 2 and 6 months
2. Change in endothelial function measured using the EndoPAT finger plethysmography system at 2 months
3. Changes in blood markers (tumour necrotising factor (TNF) alpha, brain natriuretic peptide (BNP), high sensitivity C-reactive protein (hsCRP), von Willebrand factor, E-selectin and thrombomodulin) measured using ELISA kits at 2 and 6 months
4. QT interval and dispersion measured using a 12 lead ECG at 2 and 6 months

Previous secondary outcome measures:
1. Change in blood pressure at 2 and 6 months
2. Change in endothelial function at 2 months
3. Changes in tumour necrotising factor (TNF) alpha, brain natriuretic peptide (BNP), high sensitivity C-reactive protein (hsCRP), QT interval and dispersion, von Willebrand factor, E-selectin and thrombomodulin at 2 and 6 months

Overall trial start date

30/09/2008

Overall trial end date

04/08/2011

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Confirmed diagnosis of myocardial infarction, based on the recently published Universal criteria for diagnosis of myocardial infarction: Troponin T greater than 0.02 plus one of the following:
1.1. Symptoms consistent with myocardial ischaemia
1.2. Electrocardiogram (ECG) changes consistent with myocardial ischaemia
1.3. New Q waves on ECG
1.4. New regional wall motion abnormality or evidence of new loss of viable myocardium on imaging
2. Admitted to Tayside Hospitals within 1 week of index event
3. Aged greater than 18 years, either sex
4. Minimum of 6 weeks after index event (to allow for medication stabilisation and percutaneous/surgical interventions)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Estimated glomerular filtration rate (GFR) less than 40 ml/min (using the MDRD4 method)
2. Adjusted serum calcium less than 2.15 mmol/L or greater than 2.60 mmol/L
3. Liver function tests (LFTs) greater than 3 x upper limit of normal
4. Already taking vitamin D supplements. Consumption of fish oils will not be a contraindication to enrolment as the vitamin D content is very low relative to the dose used in the study.
5. Known metastatic malignancy
6. History of renal calculi or sarcoidosis
7. Supine systolic blood pressure (BP) less than 80 mmHg
8. Pregnant, lactating, or of childbearing age and not taking reliable contraception
9. Unable to give written informed consent

Recruitment start date

01/10/2009

Recruitment end date

31/08/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Section of Ageing and Health
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Research and Innovation Services
11 Perth Road
Dundee
DD1 4HN
United Kingdom
-
j.z.houston@dundee.ac.uk

Sponsor type

University/education

Website

http://www.dundee.ac.uk/

Funders

Funder type

Charity

Funder name

Chest, Heart and Stroke Scotland (UK) (ref: Res09/A122)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol is available from the authors on request but is not available online.

IPD sharing statement
Study data are available for non-commercial, bona-fide academic analyses in collaboration with the authors; decisions on data access will be made between the investigators and the Sponsor (University of Dundee). Participant consent for unrestricted sharing of individual participant data was not obtained. Contact for data sharing: Dr Catrina Forde (c.forde@dundee.ac.uk)

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22459388

Publication citations

  1. Results

    Witham MD, Dove FJ, Khan F, Lang CC, Belch JJ, Struthers AD, Effects of vitamin D supplementation on markers of vascular function after myocardial infarction--a randomised controlled trial., Int. J. Cardiol., 2013, 167, 3, 745-749, doi: 10.1016/j.ijcard.2012.03.054.

Additional files

Editorial Notes

21/02/2018: The following changes were made: 1. Ethics approval and basic results summary were added. 2. Primary and secondary outcome measures were updated. 3. Overall trial start date was changed from 01/08/2009 to 30/09/2008. 4. Recruitment start date was changed from 01/08/2009 to 01/10/2009. 5. Recruitment end date was changed from 31/01/2011 to 31/08/2010. 6. Overall trial end date was changed from 31/01/2011 to 04/08/2011. 14/02/2018: Data sharing statement and plain English summary added.