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Is vitamin D supplementation associated with an improvement in functional capacity in older people with vitamin D insufficiency and chronic heart failure? A double blind, placebo controlled trial.
ISRCTN ISRCTN51372896
DOI 10.1186/ISRCTN51372896
ClinicalTrials.gov identifier
EudraCT number
Public title Is vitamin D supplementation associated with an improvement in functional capacity in older people with vitamin D insufficiency and chronic heart failure? A double blind, placebo controlled trial.
Scientific title
Acronym N/A
Serial number at source 2004CV12
Study hypothesis That oral administration of 100,000 U of ergocalciferol every 10 weeks will improve exercise capacity, daily activity and quality of life in older, frail heart failure patients
Lay summary
Ethics approval Not provided at time of registration
Study design Double blind, placebo controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Chronic Heart Failure
Participants - inclusion criteria 1. Age 70 years or over
2. Vitamin D levels of 20 µg/l (50 nmol/l) or less
3. Left ventricular systolic dysfunction on echocardiography, contrast ventriculography or radionuclide ventriculography
4. Clinical diagnosis of chronic heart failure, New York Heart Association class II and III
Participants - exclusion criteria 1. Mini Mental State examination score <15/30
2. Serum creatinine >200 umol/l
3. Systolic blood pressure <90 mmHg
4. Corrected calcium >2.55 mmol/l
5. Metastatic malignancy
6. Clinical diagnosis of symptomatic osteomalacia
7. Patients with a history of recurrent falls
8. Patients unable to walk without human assistance
Anticipated start date 01/06/2005
Anticipated end date 29/02/2008
Status of trial Completed
Patient information material
Target number of participants 136
Interventions 100,000 Units of oral Ergocalciferol (Vitamin D2) every 10 weeks versus placebo
Primary outcome measure(s) Six minute walk distance
Secondary outcome measure(s) 1. Timed up and go test
2. Daily activity by triaxial accelerometry
3. Health status and Quality of life (FLP and Minnesota LWHF questionnaires)
4. B-type natriuretic peptide (BNP), renin, aldosterone, angiotensin II, tumour necrosis factor (TNF) alpha
Sources of funding Biomedical and Therapeutics Research committee, Chief Scientist Office, Scottish Executive (CZB/4/300)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20103775
Contact name Dr  Miles  Witham
  Address Section of Ageing and Health
Ninewells Hospital
  City/town Dundee
  Zip/Postcode DD1 9SY
  Country United Kingdom
  Tel +44 (0)1382 632436
  Fax +44 (0)1382 660675
  Email m.witham@dundee.ac.uk
Sponsor University of Dundee (UK)
  Address Research and Innovation Services
11 Perth Road
  City/town Dundee
  Zip/Postcode DD1 4HN
  Country United Kingdom
  Tel +44 (0)1382 344943
  Fax +44 (0)1382 345423
  Email f.j.hogarth@dundee.ac.uk
Date applied 04/07/2005
Last edited 28/01/2010
Date ISRCTN assigned 03/08/2005
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