Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Douglas Seals, University of Colorado, Boulder
ClinicalTrials.gov Identifier:
NCT01566084
First received: March 23, 2012
Last updated: May 20, 2014
Last verified: May 2014
Results First Received: May 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Slow sodium tablets
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Slow Sodium Tablets (Start)

Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.

Subjects then cross over to the opposite condition in the second half of the study.

Placebo

Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.

Subjects then cross over to the opposite condition in the second half of the study.


Participant Flow:   Overall Study
    Slow Sodium Tablets (Start)     Placebo  
STARTED     7     10  
COMPLETED     7     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
11 Men and 6 post-menopausal women were enrolled.

Reporting Groups
  Description
Slow Sodium Tablets (Start)

Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a slow sodium tablets to bring them back up to a normal salt intake. This is administered through 10 tablets day.

Subjects then cross-over to the placebo arm in the second half of the study.

Placebo (Start)

Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.

Subjects then cross over to the slow sodium tablet arm in the second half of the study.

Total Total of all reporting groups

Baseline Measures
    Slow Sodium Tablets (Start)     Placebo (Start)     Total  
Number of Participants  
[units: participants]
  7     10     17  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  62  ± 7     62  ± 7     62  ± 7  
Gender  
[units: participants]
     
Female     3     3     6  
Male     4     7     11  



  Outcome Measures
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1.  Primary:   Improved Flow Mediated Dilation   [ Time Frame: Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first) ]

2.  Secondary:   Vascular Oxidative Stress   [ Time Frame: Week 5 and Week 10 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the complexity, burden, and, in some cases, invasiveness of the study design and procedures, only a limited number of subjects could be studied.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Kristen Jablonski
Organization: University of Colorado Denver
phone: 303-724-4842
e-mail: KRISTEN.NOWAK@UCDENVER.EDU


No publications provided


Responsible Party: Douglas Seals, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT01566084     History of Changes
Other Study ID Numbers: B5114, F31AG033994
Study First Received: March 23, 2012
Results First Received: May 20, 2014
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration