Does sodium cause endothelial dysfunction in patients with chronic kidney disease (CKD)? A pilot study
| ISRCTN | ISRCTN40689257 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40689257 |
| Secondary identifying numbers | N0112173573 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 27/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Tim Doulton
Scientific
Scientific
Consultant Nephrologist
East Kent Hospitals University NHS Foundation Trust
Renal Unit, Kent & Canterbury Hospital
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Study information
| Study design | Double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| 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 | Does sodium cause endothelial dysfunction in patients with chronic kidney disease (CKD)? A pilot study |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 13/07/2005 |
| Completion date | 29/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Not Specified |
| Target number of participants | 12 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/07/2005 |
| Date of final enrolment | 29/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Kent & Canterbury Hospital
Canterbury
CT1 3NG
United Kingdom
CT1 3NG
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Epsom and St Helier University Hospitals NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
Editorial Notes
27/04/2018: No publications found, verifying study status with principal investigator
03/03/2016: No publications found, verifying study status with principal investigator
