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.

Is Vitamin D supplementation associated with an improvement in functional capacity in older people with chronic heart failure? A double blind, placebo controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51372896

Enrollment

136

Registered

2005-08-03

Start date

2005-06-01

Completion date

Unknown

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure Circulatory System Heart failure

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Mini Mental State examination score 200 umol/l 3. Systolic blood pressure 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026