Condition category
Circulatory System
Date applied
04/07/2005
Date assigned
03/08/2005
Last edited
28/01/2010
Prospective/Retrospective
Retrospectively 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

2004CV12

Study information

Scientific title

Acronym

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

Ethics approval

Not provided at time of registration

Study design

Double blind, placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic Heart Failure

Intervention

100,000 Units of oral Ergocalciferol (Vitamin D2) every 10 weeks versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Ergocalciferol

Primary outcome measures

Six minute walk distance

Secondary outcome measures

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

Overall trial start date

01/06/2005

Overall trial end date

29/02/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

136

Participant 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

Recruitment start date

01/06/2005

Recruitment end date

29/02/2008

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
+44 (0)1382 344943
f.j.hogarth@dundee.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Biomedical and Therapeutics Research committee, Chief Scientist Office, Scottish Executive (CZB/4/300)

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

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

Publication citations

  1. Results

    Witham MD, Crighton LJ, Gillespie ND, Struthers AD, McMurdo ME, The effects of vitamin D supplementation on physical function and quality of life in older patients with heart failure: a randomized controlled trial., Circ Heart Fail, 2010, 3, 2, 195-201, doi: 10.1161/CIRCHEARTFAILURE.109.907899.

Additional files

Editorial Notes