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 https://doi.org/10.1186/ISRCTN51372896
EudraCT/CTIS number 2004-002116-28
Secondary identifying numbers 2004CV12
Submission date
04/07/2005
Registration date
03/08/2005
Last edited
28/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Miles Witham
Scientific

Section of Ageing and Health
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Phone +44 (0)1382 632436
Email m.witham@dundee.ac.uk

Study information

Study designDouble blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeTreatment
Scientific titleIs Vitamin D supplementation associated with an improvement in functional capacity in older people with chronic heart failure? A double blind, placebo controlled trial
Study objectivesThat 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(s)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
Health condition(s) or problem(s) studiedChronic Heart Failure
Intervention100,000 Units of oral Ergocalciferol (Vitamin D2) every 10 weeks versus placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Ergocalciferol
Primary outcome measureCurrent 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 measuresCurrent 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 study start date30/06/2004
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants136
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2005
Date of final enrolment31/05/2008

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Section of Ageing and Health
Dundee
DD1 9SY
United Kingdom

Sponsor information

University of Dundee (UK)
University/education

Research and Innovation Services
11 Perth Road
Dundee
DD1 4HN
Scotland
United Kingdom

Phone +44 (0)1382 344943
Email f.j.hogarth@dundee.ac.uk
ROR logo "ROR" https://ror.org/03h2bxq36

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe protocol is available from the authors on request but is not available online.
IPD sharing planStudy 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)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2010 Yes No
Basic results 28/02/2018 28/02/2018 No No

Additional files

ISRCTN51372896_BasicResults_28Feb18.pdf
Uploaded 28/02/2018

Editorial Notes

28/02/2018: The following changes were made:
1. Ethics approval, scientific title, EudraCT number, trial setting, plain english summary, participant level data and basic results summary were added.
2. Primary and secondary outocme measures were updated.
3. Overall trial start date was changed from 01/06/2005 to 30/06/2004.
4. Recruitment end date was changed from 29/02/2008 to 31/05/2008.
5. Overall trial end date was changed from 29/02/2008 to 31/12/2008.