Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
03/03/2016
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 Tim Doulton

ORCID ID

Contact details

Consultant Nephrologist
East Kent Hospitals University NHS Foundation Trust
Renal Unit
Kent & Canterbury Hospital
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0112173573

Study information

Scientific title

Does sodium cause endothelial dysfunction in patients with chronic kidney disease (CKD)? A pilot study

Acronym

Study hypothesis

We propose to test the following hypothesis; that in subjects with mild-to-moderate CKD under conditions of high sodium intake, as compared to low-normal sodium intake:
1. The ratio [ADMA] Urine :[DMA] urine is increased
2. [ADMA] plasma in increased
3. Endothelium-dependent vasodilatation is reduced

Ethics approval

Not provided at time of registration

Study design

Double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Urological and Genital Diseases: Chronic kidney disease (CKD)

Intervention

Double blind placebo controlled study of individuals with mild-to-moderate CKD. Subjects receive both Slow Sodium tablets (equivalent to 150 mmol/9 grams per day) and placebo tablets, with each administered for one week, in an order determined by random allocation. 'Study measurements' will be performed at baseline, and at the end of each week on study medications.
The specific experimental techniques are as follows:
1. Blood Pressure - Sitting and 24 hr ambulatory (taken with validated devices)
2. Routine biochemical investigations on blood and urine ( the latter to include urinary sodium & creatinine clearance)
3. Plasma & urine asymmetrical dimethylarginine (ADMA) - determined by commercially available ELISA.
4. Urinary dimethylamine (DMA) - determined by high pressure liquid chromatography
5. Forearm blood flow measurements - determined by venous occlusion plethysmography.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Essentially the 'outcome measure' is as detailed in the hypothesis above i.e. that on the high sodium part of the study (when receiving Slow Sodium tablets), participants will have increased levels of circulating (plasma) ADMA, increased urinary ADMA and reduced urinary DMA . It is also hoped that this will be paralleled by appropriate changes in endothelial function (ie that endothelium dependent forearm blood flow will occur in parallel with changes in ADMA).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

13/07/2005

Overall trial end date

29/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic kidney disease (as defined by calculated creatinine clearance of 30 to 89 ml/min/1.73m2 by Cockcroft-Gault formula)
2. 18-75 years old

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

12

Participant exclusion criteria

1. <18 or >75 years old
2. 3g/24hours of proteinuria
3. Calculated creatinine clearance<30 ml/min
4. Uncontrolled hypertension (defined as systolic BP >160 mmHg, diastolic BP>100 mmHg on/off anti hypertensive medication)
5. Diabetes mellitus
6. Tobacco smoking
7. Total fasting cholesterol .6 mmol/L
8. Uncontrolled heart failure OR active IHD (MI in last 3 months or current angina)
9. Chronic liver failure
10. Active malignancy

Recruitment start date

13/07/2005

Recruitment end date

29/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Kent & Canterbury Hospital
Canterbury
CT1 3NG
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Epsom and St Helier University Hospitals NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

03/03/2016: No publications found, verifying study status with principal investigator