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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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28 May 2018 |
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Main ID: |
ISRCTN40689257 |
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Date of registration:
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29/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Does sodium cause endothelial dysfunction in patients with chronic kidney disease (CKD)? A pilot study |
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Date of first enrolment:
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13/07/2005 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN40689257 |
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Study type:
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Interventional |
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Study design:
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Double-blind placebo-controlled study (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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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
CT1 3NG
Canterbury
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Urological and Genital Diseases: Chronic kidney disease (CKD)
Surgery
Chronic kidney disease (CKD)
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Intervention(s)
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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(s)
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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).
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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N0112173573
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Source(s) of Monetary Support
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Epsom and St Helier University Hospitals NHS Trust (UK), NHS R&D Support Funding
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Ethics review
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Status:
Approval date:
Contact:
Not provided at time of registration
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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29/12/2006 |
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URL:
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