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| [ ...Back to search results ] | [ Print-friendly version ] |
| The effects of oral vitamin D supplementation on cardiovascular disease risk in UK South Asian women |
| ISRCTN | ISRCTN75081811 |
| ClinicalTrials.gov identifier | |
| Public title | The effects of oral vitamin D supplementation on cardiovascular disease risk in UK South Asian women |
| Scientific title | The effects of oral vitamin D supplementation on cardiovascular disease risk in UK South Asian women: a randomised, placebo controlled, parallel group, double blinded study |
| Acronym | N/A |
| Serial number at source | 2007cv23; 2008-003387-18; CTA: 21726/0254/001-0001 |
| Study hypothesis |
That oral supplementation of vitamin D will improve cardiovascular function and metabolic and inflammatory parameters in South Asian women.
Please note that as of 06/02/09 this record was updated to include information on the ethics approval and the trial dates. The initial anticipated start date was 01/09/2008, and the initial anticipated end date was 01/03/2009. |
| Lay summary | |
| Ethics approval | Added 06/02/2009: Tayside Research Ethics Committee NHS gave approval on the 22nd October 2008 (ref: 08/S1402/55) |
| Study design | Randomised, placebo controlled, parallel group, double blinded study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cardiovascular disease risk |
| Participants - inclusion criteria |
1. Aged greater than or equal to 18 years
2. Female 3. Serum 25 hydroxyvitamin D less than 75 nmol/L 4. South Asian ethnicity, as defined by the participant |
| Participants - exclusion criteria |
1. Symptomatic
2. Cardiovascular disease (including previous stroke, transient ischaemic attack [TIA], angina, myocardial infarction, angioplasty, coronary bypass grafting, symptomatic peripheral vascular disease, chronic heart failure, atrial fibrillation) 3. 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. 4. Estimated glomerular filtration rate less than 40 ml/min (by four-variable Modification of Diet in Renal Disease [MDRD] equation) 5. Liver function tests (alanine aminotransferase [ALT], bilirubin, alkaline phosphatase) greater than 3 x normal. These two criteria will ensure that sufficient renal and hepatic function is available to convert vitamin D to the active 1,25 hydroxy form. 6. Unable to give written informed consent 7. Corrected calcium level of greater than 2.60 or less than 2.15 mmol/L 8. Clinical diagnosis of osteomalacia 9. History of renal calculi, sarcoidosis or metastatic malignancy. Excluding these groups will minimise the risk of side effects from vitamin D supplementation. 10. Pregnant or of child bearing age and not taking reliable contraception |
| Anticipated start date | 12/01/2009 |
| Anticipated end date | 11/07/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 60 |
| Interventions | Subjects will be given a single dose of 100,000 units of oral vitamin D3 or matching placebo. This dose will be given after baseline assessments. Ingestion will occur in the presence of the research team to ensure 100% adherence to medication. |
| Primary outcome measure(s) | Change in macrovascular endothelial function, which will be assessed by flow mediated dilation (FMD) according to standard guidelines. All measurements will be taken at the start of the study (i.e., before the intervention) and at 4 and 8 weeks post-intervention. |
| Secondary outcome measure(s) |
1. Microvascular endothelial function will be tested using Iontophoresis according to standard guidelines
2. Change in arterial stiffness as measured by pulse wave velocity using the validated SphygmoCor pulse waveform analysis system 3. Change in office blood pressure measured by oscillometric automatic blood pressure device 4. Change in metabolic and inflammatory markers: 4.1. Fasting serum lipid profiles: (COBAS Bio Autoanalyser) 4.2. Fasting glucose, glycosylated haemoglobin (HbA1c) and insulin levels: estimates of insulin resistance will be calculated using the Homeostasis Model (HOMA) (fasting glucose x fasting insulin/22.5) 4.3. Adiponectin and leptin using a commercially available enzyme-linked immunosorbent assay (ELISA) with good sensitivity and reproducibility 4.4. Plasminogen activator inhibitor-1 and tissue plasminogen activator antigen, both measured by ELISA 4.5. C-reactive protein will be measured using a high sensitivity automated turbidimetric assay 4.6. Tumour necrotising factor alpha (TNF-α) and interleukin-6 will be measured by high sensitivity ELISA 4.7. E-selectin - an adhesion molecule expressed only on activated endothelial cells, measured by ELISA 5. Change in serum 25 hydroxyvitamin D and parathyroid hormone (PTH) levels All measurements will be taken at the start of the study (i.e., before the intervention) and at 4 and 8 weeks post-intervention. |
| Sources of funding | Heart Research UK (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Faisel Khan |
| Address |
The Institute of Cardiovascular Research (TICR)
Vascular & Inflammatory Diseases Research Unit University of Dundee Ninewells Hospital & Medical School |
| City/town | Dundee |
| Zip/Postcode | DD1 9SY |
| Country | United Kingdom |
| Tel | +44 (0)1382 425574 |
| f.khan@dundee.ac.uk | |
| Sponsor | University of Dundee (UK) |
| Address |
c/o Dr James Houston
Research and Innovation Services 11 Perth Road |
| City/town | Dundee |
| Zip/Postcode | DD1 4HN |
| Country | United Kingdom |
| Tel | +44 (0)1382 384664 |
| J.Houston@dundee.ac.uk | |
| Sponsor website: | http://www.dundee.ac.uk/ |
| Date applied | 25/06/2008 |
| Last edited | 06/02/2009 |
| Date ISRCTN assigned | 04/09/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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