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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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14 January 2013 |
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Main ID: |
NCT00974636 |
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Date of registration:
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09/09/2009 |
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Primary sponsor: |
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Public title:
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Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial
BIA |
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Scientific title:
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Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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35 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00974636 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Rajiv Saran, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Individuals eligible to participate in this study must meet all of the following criteria:
- Willing and able to provide written, signed informed consent after the nature of the
study has been explained, and prior to any research-related procedures.
- Age = 18 years and = 85 years.
- Willing and able to comply with all study procedures.
- Patients with eGFR of 20 to 60 ml/min/173m2 by the abbreviated (4-variable) MDRD
equation and a relatively stable clinical course.
- Sitting systolic blood pressure = 100 mmHg prior to study entry (to exclude people at
risk from hypotension from dietary salt reduction).
Exclusion Criteria:
Individuals who meet any of the following exclusion criteria will not be eligible to
participate in the study:
- Recent acute illness (=1 month). Minor ailments such as a recovered common cold or
allergic rhinitis would not be considered as exclusion criteria but would be left to
the site PI's discretion.
- Recent hospitalization (=1 month) unless clearly for a minor elective procedure
unlikely to interfere with BIA measurements. The final decision will be left to the
site PI's discretion.
- Any psychological condition (including alcoholism) that could interfere with the
patient's ability to comply with the study protocol.
- Subjects with baseline 24-hour urinary sodium excretion =100 mmol/day.
- Amputation of a limb other than fingers or toes.
- Pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other
types of metal objects in the body (other than dental fillings).
- Coronary stents or metal suture material in the heart.
- Use of any investigational product or investigational medical device within 30 days
prior to screening, or requirement for any investigational agent prior to completion
of all scheduled study assessments.
- Weight over 300 pounds (limitation for examination table).
- Pregnancy or lactation.
- Patients with kidney diseases known to be associated with salt wasting (see above).
- Patients with atrial fibrillation as ambulatory blood pressure measurements may not
be accurate in this setting.
- Any condition that, in the view of the PI, places the subject at high risk of poor
treatment compliance or of not completing the study.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney Disease
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Intervention(s)
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Dietary Supplement: Low Salt Diet
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Dietary Supplement: Usual Salt Diet
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Primary Outcome(s)
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Primary Outcome: Change in volume status (intracellular, extracellular volume, and total body water) as measured by BIA using both whole body and segmental techniques
[Time Frame: 12 Weeks]
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Secondary ID(s)
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HUM00016384
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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