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
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