Kidney DiseaseBIANCT00974636
Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial
A study testing Low Salt Diet and Usual Salt Diet in people with Kidney Disease, run by University of Michigan at 1 site in United States.
Trial summary
ABSTRACT Background: It is well recognized that excess dietary salt intake plays a major role in the development of hypertension. Chronic Kidney Disease (CKD) is associated with excess salt and water retention (excess volume) which is associated with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Kidney Disease
- What is being tested?
- Low Salt Diet and Usual Salt Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
ABSTRACT
Background:
Read more
It is well recognized that excess dietary salt intake plays a major role in the development of hypertension. Chronic Kidney Disease (CKD) is associated with excess salt and water retention (excess volume) which is associated with hypertension.
Hypotheses:
Hypothesis 1:
Dietary salt restriction will improve volume status in subjects with CKD stages 3-4 as assessed by Bioelectrical Impedance Analysis (BIA).
Hypothesis 2:
Dietary salt restriction will result in improved blood pressure control in patients with CKD stages 3-4.
Hypothesis 3:
Dietary salt restriction will decrease albuminuria in patients with CKD stages 3-4.
Patients and Trial Design: This randomized crossover pilot study is designed to assess the effect of salt restriction on volume status in patients with CKD stages 3 and 4.
Subjects will be randomized to a treatment order: (1) 4 weeks of salt restriction of <85 mmol sodium per day, a 2 week washout period, and 4 weeks of usual salt diet, OR (2) 4 weeks of usual diet, 2 weeks washout, and 4 weeks of salt restriction. Patients will receive dietary counseling in person at each study visit and at weekly intervals by phone calls from study dieticians. At weeks 0, 4, 6 and 10, patients will undergo assessments for (i) physical examination with assessments for weight, blood pressure, pulse, anthropometrics and a standardized clinical assessment of volume status. (ii) volume status using bioelectrical impedance analysis (BIA) (iii) 24-hour urine testing for, albumin, creatinine and aldosterone Every 2 weeks throughout the study, a 24-hour urine sodium will be measured for compliance, and serum electrolytes will be assessed for safety.
Data Analysis: BIA measurements in the low salt group will be compared with the regular diet group using the standard linear model analysis for 2x2 crossover trials. Additionally, 24-hour ambulatory and static blood pressure and 24-hour urine aldosterone levels will be compared between the two groups.
Future Implications: A significant reduction in the degree of volume expansion (as assessed by BIA) and blood pressure as a result of a salt restricted diet would have implications for renal and cardiovascular protection and would warrant confirmation by a larger randomized trial.
- Conditions
- Kidney Disease
- Being tested
- Low Salt Diet, Usual Salt Diet
- Keywords
- Kidney Disease, Albuminuria, Glomerular filtration rate, Volume status, Bioimpedance analysis
- Medical subject headings
- Kidney Diseases, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Salt DietDietary supplement
Also called Low salt diet, CKD, Bioimpedance analysis (BIA)
Dietary sodium restriction of ≤2.0 g/day or ≤ 85 mmol/day
Usual Salt DietDietary supplement
Usual salt intake (approximately >180-200 mmol/day in the average American diet).
| Study group | Role | What they receive |
|---|---|---|
| Low Salt Diet | Experimental | Dietary sodium restriction of ≤2.0 g/day or ≤ 85 mmol/day for two weeks Receives: Dietary Supplement: Low Salt Diet |
| Ususal Salt Diet | Placebo comparator | Usual salt intake (approximately >180-200 mmol/day in the average American diet). Receives: Dietary Supplement: Usual Salt Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Change in volume status (intracellular, extracellular volume, and total body water) as measured by BIA using both whole body and segmental techniques
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Renal Research Institute
- Responsible party
- Principal investigator, Rajiv Saran, University of Michigan
- Investigators
- Rajiv Saran, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974636
- Sponsor's protocol ID
- HUM00016384
- Acronym
- BIA
- Status last verified
- Aug 2015
- First submitted
- 9 Sep 2009
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
PubMed 34164803
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT00974636
- Acronym / sponsor ID
- BIA / HUM00016384
- Conditions
- Kidney Disease
- Keywords
- Kidney Disease, Albuminuria, Glomerular filtration rate, Volume status, Bioimpedance analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Renal Research Institute
- Study start
- May 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ABSTRACT
Background:
It is well recognized that excess dietary salt intake plays a major role in the development of hypertension. Chronic Kidney Disease (CKD) is associated with excess salt and water retention (excess volume) which is associated with hypertension.
Hypotheses:
Hypothesis 1:
Dietary salt restriction will improve volume status in subjects with CKD stages 3-4 as assessed by Bioelectrical Impedance Analysis (BIA).
Hypothesis 2:
Dietary salt restriction will result in improved blood pressure control in patients with CKD stages 3-4.
Hypothesis 3:
Dietary salt restriction will decrease albuminuria in patients with CKD stages 3-4.
Patients and Trial Design: This randomized crossover pilot study is designed to assess the effect of salt restriction on volume status in patients with CKD stages 3 and 4.
Subjects will be randomized to a treatment order: (1) 4 weeks of salt restriction of <85 mmol sodium per day, a 2 week washout period, and 4 weeks of usual salt diet, OR (2) 4 weeks of usual diet, 2 weeks washout, and 4 weeks of salt restriction. Patients will receive dietary counseling in person at each study visit and at weekly intervals by phone calls from study dieticians. At weeks 0, 4, 6 and 10, patients will undergo assessments for (i) physical examination with assessments for weight, blood pressure, pulse, anthropometrics and a standardized clinical assessment of volume status. (ii) volume status using bioelectrical impedance analysis (BIA) (iii) 24-hour urine testing for, albumin, creatinine and aldosterone Every 2 weeks throughout the study, a 24-hour urine sodium will be measured for compliance, and serum electrolytes will be assessed for safety.
Data Analysis: BIA measurements in the low salt group will be compared with the regular diet group using the standard linear model analysis for 2x2 crossover trials. Additionally, 24-hour ambulatory and static blood pressure and 24-hour urine aldosterone levels will be compared between the two groups.
Future Implications: A significant reduction in the degree of volume expansion (as assessed by BIA) and blood pressure as a result of a salt restricted diet would have implications for renal and cardiovascular protection and would warrant confirmation by a larger randomized trial.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Salt Diet | Experimental | Dietary Supplement: Low Salt DietDietary sodium restriction of ≤2.0 g/day or ≤ 85 mmol/day for two weeks |
| Ususal Salt Diet | Placebo comparator | Dietary Supplement: Usual Salt DietUsual salt intake (approximately >180-200 mmol/day in the average American diet). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Salt DietAlso: Low salt diet, CKD, Bioimpedance analysis (BIA)Dietary sodium restriction of ≤2.0 g/day or ≤ 85 mmol/day | Dietary supplement | Low Salt Diet |
| Usual Salt DietUsual salt intake (approximately >180-200 mmol/day in the average American diet). | Dietary supplement | Ususal Salt Diet |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
- Derived from this study: PubMed 34164803McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajiv Saran, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Salt Diet and Usual Salt Diet in people with Kidney Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00974636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.