Study of vitamin D therapy to improve heart function and immune response in patients with chronic kidney disease (CKD)
| ISRCTN | ISRCTN47936804 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47936804 |
| Secondary identifying numbers | 10/H0709/56 |
- Submission date
- 05/12/2010
- Registration date
- 05/04/2011
- Last edited
- 13/12/2019
- 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
Not provided at time of registration
Contact information
Dr David Goldsmith
Scientific
Scientific
Consultant Nephrologist and Reader in Renal Medicine
Guy's and St. Thomas' Hospital NHS Trust
Renal Offices
5th Floor Borough Wing
Great Maze Pond
London
SE1 9RT
United Kingdom
Study information
| Study design | Randomised double-blind placebo-controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Impact of vitamin D supplementation on left ventricular mass on cardiac magnetic resonance imaging and immune regulation in chronic kidney disease: a randomised placebo-controlled trial |
| Study acronym | The 5C study |
| Study objectives | Native vitamin D repletion results in immune modulation and regression of left ventricular hypertrophy in vitamin D deficient non-dialysis dependent chronic kidney disease (CKD) patients. |
| Ethics approval(s) | North London Research Ethics Committee (REC) 3, 02/06/2010, ref: 10/H0709/56 |
| Health condition(s) or problem(s) studied | Left ventricular hypertrophy (LVH) in patients with non-dialysis dependent chronic kidney disease (CKD stage 3b and 4) |
| Intervention | Oral cholecalciferol therapy 100,000 IU at week 0, 4, 8, 12, 24 and 42 or matching placebo. |
| Intervention type | Supplement |
| Primary outcome measure | 1. 10g improvement in left ventricular mass (LVM) with oral vitamin D therapy over 1 year 2. Difference in LVM in patients treated with vitamin D compared to controls Measured at 52 weeks from enrolment. |
| Secondary outcome measures | 1. Reduction in cardiac fibrosis determined by biomarkers of cardiac fibrosis in serum post vitamin D3 therapy 2. Augmentation of adaptive immune response to Hepatitis B vaccination post oral vitamin D3 supplementation 3. Immune regulation with predominantly antiinflammatory response with oral vitamin D3 therapy 4. Measured at 52 weeks from enrolment. |
| Overall study start date | 10/01/2011 |
| Completion date | 10/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 participants randomised 1:1 into two groups |
| Total final enrolment | 48 |
| Key inclusion criteria | 1. Patients aged 18 - 75 years with CKD stage 3b-4 2. Documented 25 hydroxy vitamin D defeciency/insufficiency with serum 25 (OH)D levels between 12.5 to 75 nmol/L 3. Left ventricular mass index (LVMI) between 80 - 160 g/m2 for females and 100 - 160 g/m2 for males 4. Patients on angiotensin converting enzyme inhibitors and/or angiotensin II receptor blockers |
| Key exclusion criteria | 1. Presence of diabetes mellitus (type I and II) 2. Serum calcium greater than 2.55 mmol/L 3. Anaemia (Hb less than 10.0 g/dL or taking regular erythropoiesis stimulating agents) 4. Known malignancy 5. History of congestive cardiac failure or ejection fraction less than 40% on ECHO and/or plasma NT-proBNP greater than 500 pg/ml 6. Uncontrolled hypertension (blood pressure [BP] greater than 150/90 mmHg despite anti-hypertensive medication) 7. Significant valvular heart disease identified on transthoracic ECHO 8 Conditions that may influence collagen metabolism such as recent (less than 6 months) surgery or trauma, fibrotic diseases or active inflammatory conditions 9. Immunosuppressive medications 10. Presence of arterio-venous fistula for dialysis access 11. History of previous myocardial infarction (Trop T greater than 0.5) |
| Date of first enrolment | 10/01/2011 |
| Date of final enrolment | 10/03/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Guy's and St. Thomas' Hospital NHS Trust
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Guy's and St. Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Office
16th Floor
Guys Tower
Great Maze Pond
St. Thomas' Street
London
SE1 9RT
England
United Kingdom
| karen.ignatian@gstt.nhs.uk | |
| Website | http://www.guysandstthomas.nhs.uk/ |
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Charity
Guy's and St Thomas' Charity (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
- Location
- United Kingdom
British Heart Foundation (BHF) (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/12/2019 | 13/12/2019 | Yes | No |
Editorial Notes
13/12/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The condition has been changed from "Non-dialysis dependent chronic kidney disease (CKD stage 3b and 4)" to "Left ventricular hypertrophy (LVH) in patients with non-dialysis dependent chronic kidney disease (CKD stage 3b and 4)" and the condition category changed from 'Urological and Genital diseases' to 'Circulatory System'.
11/12/2019: The intention to publish date has been added.
13/12/2017: No publications found, verifying study status with principal investigator.
