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ISRCTN
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ISRCTN40689257
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ClinicalTrials.gov identifier
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Public title
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Does sodium cause endothelial dysfunction in patients with chronic kidney disease (CKD)? A pilot study
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0112173573
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Double blind placebo controlled study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Urological and Genital Diseases: Chronic kidney disease (CKD)
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Participants - inclusion criteria
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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. 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
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Participants - exclusion criteria
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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
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Anticipated start date
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13/07/2005
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Anticipated end date
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29/12/2006
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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12
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Interventions
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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.
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Primary outcome measure(s)
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Essentially the 'outcome measure' is as detailed in the hypothesis above ie 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).
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Epsom and St Helier University Hospitals NHS Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
Tim
Doulton
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Address
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Consultant Nephrologist
East Kent Hospitals University NHS Foundation Trust
Renal Unit, Kent & Canterbury Hospital
Ethelbert Road
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City/town
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Canterbury
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Zip/Postcode
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CT1 3NG
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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05/08/2009
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Date ISRCTN assigned
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29/09/2006
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