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Effects of Low Sodium Intake on the Anti-proteinuric Efficacy in Hypertensive Patient With Olmesartan (ESPECIAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552954
First Posted: March 13, 2012
Last Update Posted: December 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Daiichi Sankyo, Inc.
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Ho Jun Chin, Seoul National University Bundang Hospital
Results First Submitted: October 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hypertension
Chronic Kidney Disease
Microalbuminuria
Intervention: Behavioral: Intensive education of low salt diet

  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
Patients were selected from 7 centers in Korea (Seoul National University Boramae Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Konkuk University Hospital, Dongguk University Ilsan Hospital, Kyung Hee University Medical Center, and Seoul St. Mary’s Hospital) and enrolled from Mar. 2012 to Mar. 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We screened 312 patients before 8 weeks of study initiation, and 269 patients were enrolled. During the 1st 8 weeks of this study (ARB run-in), 13 patients were withdrawn. After that, 256 patients were randomized, 11 participants were dropped out between 8th week and 16th week, and 245 who completed the trial were included in the analysis .

Reporting Groups
  Description
Conventional Education of Low-salt Diet Group Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
Intensive Education of Low-salt Diet Group

For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.

Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.


Participant Flow:   Overall Study
    Conventional Education of Low-salt Diet Group   Intensive Education of Low-salt Diet Group
STARTED   131 [1]   125 
COMPLETED   126   119 
NOT COMPLETED   5   6 
Adverse Event                1                2 
Lost to Follow-up                1                1 
Withdrawal by Subject                1                1 
Protocol Violation                1                2 
diagnosed DM                1                0 
[1] A total of 13 patients were withdrawn from 269 patients. The remained 256 patients were randomized.



  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.
No text entered.

Reporting Groups
  Description
Conventional Education of Low-salt Diet Group Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
Intensive Education of Low-salt Diet Group

For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.

Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.

Total Total of all reporting groups

Baseline Measures
   Conventional Education of Low-salt Diet Group   Intensive Education of Low-salt Diet Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 131   125   256 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   107   116   223 
>=65 years   24   9   33 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.7  (14.3)   48.2  (12.2)   49.5  (13.3) 
Gender 
[Units: Participants]
     
Female   64   54   118 
Male   67   71   138 
Region of Enrollment 
[Units: Participants]
     
Korea, Republic of   131   125   256 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   ∆Albuminuria by 24-hour Urine Protein Excretion   [ Time Frame: changes from week 8 at week 16 (week 8 - week 16) ]

2.  Secondary:   ∆Hemoglobin (0 Week - 16 Weeks)   [ Time Frame: 0 week, 16 weeks ]

3.  Secondary:   Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16   [ Time Frame: week 8 and week 16 ]

4.  Secondary:   Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16   [ Time Frame: week 8 and week 16 ]


  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
The major limitation of this study is that we used a 24-hour volume urine collected at a single time point for each follow-up visit. Urine excretion can be influenced by the sodium intake of individual patients at certain point.


  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: Ho Jun Chin
Organization: Department of Internal Medicine, Seoul National University Bundang Hospital
phone: +82-10-7360-7025
e-mail: mednep@snubh.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ho Jun Chin, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01552954     History of Changes
Other Study ID Numbers: B-1112/142-008
First Submitted: February 24, 2012
First Posted: March 13, 2012
Results First Submitted: October 30, 2013
Results First Posted: December 18, 2014
Last Update Posted: December 18, 2014