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ISRCTN
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ISRCTN32927244
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ClinicalTrials.gov identifier
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Public title
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Vitamin D After Myocardial Infarction (MI): the DAMI study
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Scientific title
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Effects of vitamin D supplementation on markers of vascular function after myocardial infarction: a placebo controlled, double blind, parallel group, randomised controlled trial
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Acronym
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DAMI
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Serial number at source
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2008CV05
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Placebo-controlled double-blind parallel group randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Myocardial infarction
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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
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Anticipated start date
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01/08/2009
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Anticipated end date
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31/01/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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80
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Interventions
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100,000 units of oral vitamin D or placebo at 0, 2 and 4 months. Total follow up is 6 months per patient.
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Primary outcome measure(s)
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Change in endothelial function between baseline and 6 months.
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Secondary outcome measure(s)
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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
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Sources of funding
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Chest, Heart and Stroke Scotland (UK) (ref: Res09/A122)
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Trial website
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Publications
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Contact name
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Dr
Miles
Witham
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Address
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Section of Ageing and Health
Ninewells Hospital
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Tel
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+44 (0)1382 632436
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Fax
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+44 (0)1382 660675
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Email
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m.witham@dundee.ac.uk
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Sponsor
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University of Dundee (UK)
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Address
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Research and Innovation Services
11 Perth Road
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City/town
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Dundee
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Zip/Postcode
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DD1 4HN
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Country
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United Kingdom
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Email
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j.z.houston@dundee.ac.uk
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Sponsor website:
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http://www.dundee.ac.uk/
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Date applied
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05/01/2009
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Last edited
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30/01/2009
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Date ISRCTN assigned
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30/01/2009
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