Condition category
Circulatory System
Date applied
05/01/2009
Date assigned
30/01/2009
Last edited
03/04/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

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

Not provided at time of registration

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 measures

Change in endothelial function between baseline and 6 months.

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

01/08/2009

Overall trial end date

31/01/2011

Reason abandoned

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

01/08/2009

Recruitment end date

31/01/2011

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 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