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.

Not Applicable

Completed

• Conditions: Chronic Heart Failure; Circulatory System; Heart failure

• Registration Number: ISRCTN51372896
• Lead Sponsor: niversity of Dundee (UK)

Brief Summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20103775

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-03
• Study Completion: 2008-12-31
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 136

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure (as of 28/02/2018):<br>Six minute walk distance measured using the six minute walk test at baseline, 10 and 20 weeks.<br><br>Previous primary outcome measure:<br>Six minute walk distance

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures (as of 28/02/2018):<br>1. Mobility is measured using the Timed Up and Go test at baseline, 10 and 20 weeks<br>2. Daily activity is measured by triaxial accelerometry at baseline, 10 and 20 weeks<br>3. Health status and Quality of life are measured using FLP and Minnesota LWHF questionnaires at baseline, 10 and 20 weeks<br>4. B-type natriuretic peptide (BNP), renin, aldosterone, and tumour necrosis factor (TNF) alpha are measured using ELISA assays at baseline, 10 and 20 weeks<br>5. Vitamin D deficiency is measured using the 25OHD test at baseline, 10 and 20 weeks<br><br>Previous secondary outcome measures:<br>1. Timed up and go test<br>2. Daily activity by triaxial accelerometry<br>3. Health status and Quality of life (FLP and Minnesota LWHF questionnaires)<br>4. B-type natriuretic peptide (BNP), renin, aldosterone, angiotensin II, tumour necrosis factor (TNF) alpha