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

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ClinicalTrials.gov Identifier: NCT01552954
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : December 18, 2014
Last Update Posted : December 18, 2014
Sponsor:
Collaborators:
Daiichi Sankyo, Inc.
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Ho Jun Chin, Seoul National University Bundang Hospital

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
Enrollment 269
Recruitment Details 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 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 During the 1st 8 weeks of this study (ARB run-in), 13 patients were withdrawn.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 .
Arm/Group Title Conventional Education of Low-salt Diet Group Intensive Education of Low-salt Diet Group
Hide Arm/Group Description Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.

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.

Period Title: Overall Study
Started 131 [1] 125
Completed 126 119
Not Completed 5 6
Reason Not Completed
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.
Arm/Group Title Conventional Education of Low-salt Diet Group Intensive Education of Low-salt Diet Group Total
Hide Arm/Group Description Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.

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 of all reporting groups
Overall Number of Baseline Participants 131 125 256
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 125 participants 256 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
107
  81.7%
116
  92.8%
223
  87.1%
>=65 years
24
  18.3%
9
   7.2%
33
  12.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants 125 participants 256 participants
50.7  (14.3) 48.2  (12.2) 49.5  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 125 participants 256 participants
Female
64
  48.9%
54
  43.2%
118
  46.1%
Male
67
  51.1%
71
  56.8%
138
  53.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 131 participants 125 participants 256 participants
131 125 256
1.Primary Outcome
Title ∆Albuminuria by 24-hour Urine Protein Excretion
Hide Description

Change in albuminuria as a 24-hour urine protein excretion by intensive education of low salt diet during taking olmesartan

*In outcome measure data table, the 24-hour urine collection at 16th week was omitted in 3 out of 245 patients (1 for intensive education group and 2 for conventional education group). Values of each study week were “mean” of all participants on specific study week, but “∆albuminuria (week 8 - week 16)” value was “mean” of ∆ values of “8 weeks-16 weeks” in each individuals. Therefore, values of 3 patients were excluded in “mean of ∆albuminuria (week 8 - week 16)”. That's why simple subtraction (week 8 - week 16) of values are not matched with the data.

Time Frame changes from week 8 at week 16 (week 8 - week 16)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Education of Low-salt Diet Group Intensive Education of Low-salt Diet Group
Hide Arm/Group Description:
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.

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.

Overall Number of Participants Analyzed 126 119
Mean (Standard Deviation)
Unit of Measure: mg/day
24hr-urine albumin (8th week) 483.5  (646.7) 569.9  (718.9)
24hr-urine albumin (16th week);n=124, 118 487.3  (688.8) 417.4  (597.0)
Mean of ∆albuminuria (week 8-week 16); n=124, 118 -0.4  (371.9) 154.0  (489.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Education of Low-salt Diet Group, Intensive Education of Low-salt Diet Group
Comments Differences with two-tailed P<0.05 were considered statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments for albuminuria changes from week 8 at week 16 (week 8 - week 16)
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Conventional Education of Low-salt Diet Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments for 24-hour urine albumin excretion between 8 weeks and 16 weeks
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Intensive Education of Low-salt Diet Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments for 24-hour urine albumin excretion between 8 weeks and 16 weeks in intensive education group
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title ∆Hemoglobin (0 Week - 16 Weeks)
Hide Description The change of hemoglobin after prescription of Olmesartan
Time Frame 0 week, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Education of Low-salt Diet Group Intensive Education of Low-salt Diet Group
Hide Arm/Group Description:
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.

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.

Overall Number of Participants Analyzed 126 119
Mean (Standard Deviation)
Unit of Measure: g/dL
Hemoglobin (week 0) 13.8  (1.7) 14.0  (1.8)
Hemoglobin (week 8) 13.5  (1.8) 13.7  (1.7)
Hemoglobin (week 16) 13.3  (1.7) 13.4  (1.7)
Hemoglobin changes from week 0 at week 16 0.46  (0.90) 0.62  (0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Education of Low-salt Diet Group, Intensive Education of Low-salt Diet Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.187
Comments for hemoglobin changes from week 0 at week 16 (week 0 - week 16)
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16
Hide Description Change of sodium excretion rate in 24 hour-urine collection by intensive education for low salt diet at week 16
Time Frame week 8 and week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Education of Low-salt Diet Group Intensive Education of Low-salt Diet Group
Hide Arm/Group Description:
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.

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.

Overall Number of Participants Analyzed 126 119
Mean (Standard Deviation)
Unit of Measure: mEq/day
week 8 155.5  (71.1) 157.4  (74.7)
week 16; n=124, 118 147.1  (66.1) 122.1  (59.9)
∆Na excretion (week 8 - week 16);n=124, 118 9.0  (54.5) 35.4  (64.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Education of Low-salt Diet Group, Intensive Education of Low-salt Diet Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments for changes from week 8 at week 16 (week 8 - week 16)
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16
Hide Description Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16 in the Intensive Education Group compared to the Conventional Education Group
Time Frame week 8 and week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Education of Low-salt Diet Group Intensive Education of Low-salt Diet Group
Hide Arm/Group Description:
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.

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.

Overall Number of Participants Analyzed 126 119
Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic BP at week 8 121.8  (18.4) 122.1  (14.0)
Systolic BP at week 16 121.2  (14.9) 120.4  (14.9)
sBP changes from week 8 at week 16 0.6  (15.1) 1.7  (14.6)
Diastolic BP at week 8 73.4  (11.6) 73.6  (11.0)
Diastolic BP at week 16 74.8  (10.5) 73.1  (10.4)
dBP changes from week 8 at week 16 -0.7  (10.0) 0.5  (9.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Education of Low-salt Diet Group, Intensive Education of Low-salt Diet Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments for sBP changes from week 8 at week 16 (week 8 - week 16)
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Conventional Education of Low-salt Diet Group, Intensive Education of Low-salt Diet Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.585
Comments for dBP changes from week 8 at week 16 (week 8 - week 16)
Method t-test, 2 sided
Comments [Not Specified]
Time Frame from week 8 to week 16 (for 8 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conventional Education of Low-salt Diet Group Intensive Education of Low-salt Diet Group
Hide Arm/Group Description Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.

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.

All-Cause Mortality
Conventional Education of Low-salt Diet Group Intensive Education of Low-salt Diet Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Education of Low-salt Diet Group Intensive Education of Low-salt Diet Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/131 (0.00%)      0/125 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Conventional Education of Low-salt Diet Group Intensive Education of Low-salt Diet Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/131 (0.76%)      2/125 (1.60%)    
Nervous system disorders     
Headache  [1]  1/131 (0.76%)  1 0/125 (0.00%)  0
Renal and urinary disorders     
Elevated serum creatinine  [2]  0/131 (0.00%)  0 2/125 (1.60%)  2
Indicates events were collected by systematic assessment
[1]
Headache
[2]
Elevation of serum creatinine level : Physician assessed ARB could not be continued
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.
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
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