Plain English Summary
Background and study aims
Small studies have shown that vitamin D, a hormone that the skin usually makes using sunshine, may be able to improve muscle function pressure in some people. The majority of people in Scotland have low levels of vitamin D, and we know that people with heart failure have both low vitamin D levels and weaker muscles than usual. The weakness of the muscles is one of the reasons why people with heart failure become tired and breathless easily.
The aim of the study is to find out if giving extra vitamin D to people who have heart failure helps to improve muscle function, and see if giving vitamin D can improve some other measures of heart function and inflammation that are affected by heart failure.
Who can participate?
Adults aged 70 years or over with chronic heart failure
What does the study involve?
The study lasts for 20 weeks. Participants are randomly allocated into one of two groups, and given either a capsule of vitamin D or a placebo (dummy) at the start of the study, and then again 10 weeks later.
Participants are assessed at the start, and at 10 and 20 weeks. Each visit will 1.5 hours. At each visit, participants have some or all of the following are measured, depending on which visit it is:
- Blood pressure
- Take a blood sample
- Walk up and down a corridor for six minutes to see how far they can walk
- Time you whilst you get out of a chair and walk a few paces
- Wear a small box (accelerometer) on their waistband during the day for a week. This records movement, to measure how active you are.
- Answer two questionnaires about quality of life and heart failure symptoms
What are the possible benefits and risks of participating?
Although this dose of vitamin D has been used before and is known to be safe there is a small possibility of side effects. Participants are closely monitored for side effects caused by high calcium levels: sickness, diarrhoea, thirst or dizziness. To reduce the chance of vitamin D increasing the calcium level in their blood, participants are asked not to take vitamin D supplements or calcium supplements whilst taking part in this study.
Having blood taken can cause some bruising. The blood pressure cuff causes mild discomfort to some people. Participants may feel tired after the six minute walk depending on how much walking they usually do.
Where is the study run from?
Ninewells Hospital Dundee (UK)
When is the study starting and how long is it expected to run for?
June 2004 to December 2008
Who is funding the study?
Biomedical and Therapeutics Research Committee (UK)
Who is the main contact?
Dr Miles Witham (Scientific)
m.witham@dundee.ac.uk
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
2004-002116-28
ClinicalTrials.gov number
Protocol/serial number
2004CV12
Study information
Scientific title
Is Vitamin D supplementation associated with an improvement in functional capacity in older people with chronic heart failure? A double blind, placebo controlled trial
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
1. Tayside Research Ethics Committee, 21/9/2004, ref: 04/S1401/128
2. Fife and Forth Valley Research Ethics Committee, 15/02/2008, ref: 08/S0501/13
Study design
Double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
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 measure
Current primary outcome measure (as of 28/02/2018):
Six minute walk distance measured using the six minute walk test at baseline, 10 and 20 weeks.
Previous primary outcome measure:
Six minute walk distance
Secondary outcome measures
Current secondary outcome measures (as of 28/02/2018):
1. Mobility is measured using the Timed Up and Go test at baseline, 10 and 20 weeks
2. Daily activity is measured by triaxial accelerometry at baseline, 10 and 20 weeks
3. Health status and Quality of life are measured using FLP and Minnesota LWHF questionnaires at baseline, 10 and 20 weeks
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
5. Vitamin D deficiency is measured using the 25OHD test at baseline, 10 and 20 weeks
Previous 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
30/06/2004
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
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
31/05/2008
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
The protocol is available from the authors on request but is not available online.
IPD sharing statement:
Study data are available for non-commercial, bona-fide academic analyses in collaboration with the authors; decisions on data access will be made between the investigators and the Sponsor (University of Dundee). Participant consent for unrestricted sharing of individual participant data was not obtained
Contact for data sharing: Dr Catrina Forde (c.forde@dundee.ac.uk)
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20103775
Publication citations
-
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
- ISRCTN51372896_BasicResults_28Feb18.pdf Uploaded 28/02/2018