Condition category
Urological and Genital Diseases
Date applied
05/12/2010
Date assigned
05/04/2011
Last edited
21/07/2015
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 David Goldsmith

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10/H0709/56

Study information

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

Acronym

The 5C study

Study hypothesis

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

North London Research Ethics Committee (REC) 3, 02/06/2010, ref: 10/H0709/56

Study design

Randomised double-blind placebo-controlled multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Vitamin D

Primary outcome measures

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 trial start date

10/01/2011

Overall trial end date

10/03/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 participants randomised 1:1 into two groups

Participant 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)

Recruitment start date

10/01/2011

Recruitment end date

10/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's and St. Thomas' Hospital NHS Trust
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Guy's and St. Thomas' NHS Foundation Trust (UK)

Sponsor details

Research and Development Office
16th Floor
Guys Tower
Great Maze Pond
St. Thomas' Street
London
SE1 9RT
United Kingdom
-
karen.ignatian@gstt.nhs.uk

Sponsor type

Government

Website

http://www.guysandstthomas.nhs.uk/

Funders

Funder type

Charity

Funder name

Guy's and St Thomas' Charity (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

British Heart Foundation (BHF) (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes