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Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

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ClinicalTrials.gov Identifier: NCT01574157
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Chronic Renal Insufficiency
Diabetes Mellitus
Interventions Drug: Sodium bicarbonate
Drug: Placebo
Enrollment 74
Recruitment Details Participants were recruited from VA Salt Lake City Healthcare System from November 2012 to October 2017.
Pre-assignment Details  
Arm/Group Title Sodium Bicarbonate Placebo
Hide Arm/Group Description Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months. Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
Period Title: Overall Study
Started 35 39
Month 3 31 33
Completed [1] 31 31
Not Completed 4 8
Reason Not Completed
Withdrawal by Subject             4             5
Lost to Follow-up             0             3
[1]
Month 6
Arm/Group Title Sodium Bicarbonate Placebo Total
Hide Arm/Group Description Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses. Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months. Total of all reporting groups
Overall Number of Baseline Participants 35 39 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 39 participants 74 participants
70  (8) 73  (8) 72  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 39 participants 74 participants
Female
1
   2.9%
1
   2.6%
2
   2.7%
Male
34
  97.1%
38
  97.4%
72
  97.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 39 participants 74 participants
Hispanic or Latino
3
   8.6%
4
  10.3%
7
   9.5%
Not Hispanic or Latino
32
  91.4%
35
  89.7%
67
  90.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 39 participants 74 participants
American Indian or Alaska Native
1
   2.9%
1
   2.6%
2
   2.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   2.6%
1
   1.4%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
32
  91.4%
36
  92.3%
68
  91.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   5.7%
1
   2.6%
3
   4.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 35 participants 39 participants 74 participants
35
 100.0%
39
 100.0%
74
 100.0%
Estimated glomerular filtration rate  
Mean (Standard Deviation)
Unit of measure:  Ml/min/1.73m2
Number Analyzed 35 participants 39 participants 74 participants
50  (20) 52  (16) 51  (18)
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 35 participants 39 participants 74 participants
129  (12) 127  (11) 128  (12)
Use of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin receptor blocker (ARB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 39 participants 74 participants
28
  80.0%
34
  87.2%
62
  83.8%
Total body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 35 participants 39 participants 74 participants
100  (18) 101  (22) 101  (20)
Lean body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 35 participants 39 participants 74 participants
67  (8) 68  (9) 68  (9)
Congestive heart failure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 39 participants 74 participants
1
   2.9%
4
  10.3%
5
   6.8%
Serum total carbon dioxide (CO2)  
Mean (Standard Deviation)
Unit of measure:  meq/L
Number Analyzed 35 participants 39 participants 74 participants
24  (3) 24  (2) 24  (2)
Serum potassium  
Mean (Standard Deviation)
Unit of measure:  meq/L
Number Analyzed 35 participants 39 participants 74 participants
4.2  (0.4) 4.3  (0.4) 4.2  (0.4)
Hemoglobin A1c  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 35 participants 39 participants 74 participants
7.5  (1.0) 7.6  (1.3) 7.5  (1.1)
Urinary albumin/creatinine  
Median (Inter-Quartile Range)
Unit of measure:  Mg/g
Number Analyzed 35 participants 39 participants 74 participants
121
(84 to 412)
131
(46 to 324)
121
(58 to 370)
Urinary pH  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 35 participants 39 participants 74 participants
5.6  (0.4) 5.4  (0.4) 5.5  (0.4)
Urinary ammonium  
Mean (Standard Deviation)
Unit of measure:  Meq/d
Number Analyzed 35 participants 39 participants 74 participants
36  (18) 33  (21) 34  (20)
Urinary titratable acids  
Mean (Standard Deviation)
Unit of measure:  Meq/d
Number Analyzed 35 participants 39 participants 74 participants
32  (14) 31  (16) 32  (15)
Urinary transforming growth factor-B1/creatinine  
Median (Inter-Quartile Range)
Unit of measure:  Ng/g
Number Analyzed 35 participants 39 participants 74 participants
122
(79 to 186)
103
(68 to 147)
112
(74 to 157)
Urinary kidney injury molecule-1/creatinine  
Median (Inter-Quartile Range)
Unit of measure:  Ng/mg
Number Analyzed 35 participants 39 participants 74 participants
0.91
(0.57 to 1.87)
0.88
(0.59 to 1.89)
0.89
(0.58 to 1.87)
Urinary fibronectin/creatinine  
Median (Inter-Quartile Range)
Unit of measure:  Ng/mg
Number Analyzed 35 participants 39 participants 74 participants
107
(75 to 194)
97
(65 to 147)
102
(74 to 173)
Urinary neutrophil gelatinase-associated lipocalin/creatinine  
Median (Inter-Quartile Range)
Unit of measure:  Ng/mg
Number Analyzed 35 participants 39 participants 74 participants
10.5
(7.0 to 23.6)
11.9
(6.3 to 24.0)
11.1
(6.5 to 23.8)
1.Primary Outcome
Title Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)
Hide Description Urinary TGF-b1 is considered a marker of renal fibrosis
Time Frame The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Bicarbonate Placebo
Hide Arm/Group Description:

Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months

Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.

Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.

Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.

Overall Number of Participants Analyzed 35 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent change
7.6
(-9.6 to 28.0)
-4.4
(-19.4 to 13.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Bicarbonate, Placebo
Comments The primary analysis compared the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.6
Confidence Interval (2-Sided) 95%
-9.6 to 40.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)
Hide Description KIM-1 is a marker of of kidney injury.
Time Frame The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Bicarbonate Placebo
Hide Arm/Group Description:
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months.
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
Overall Number of Participants Analyzed 35 39
Mean (95% Confidence Interval)
Unit of Measure: percent change
-11.4
(-33.0 to 17.0)
-1.5
(-24.9 to 29.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Bicarbonate, Placebo
Comments The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.1
Confidence Interval (2-Sided) 95%
-38.2 to 30.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)
Hide Description NGAL is a marker of kidney injury
Time Frame The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Bicarbonate Placebo
Hide Arm/Group Description:

Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months

Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.

Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.

Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.

Overall Number of Participants Analyzed 35 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent change
-28.5
(-48.7 to -0.3)
5.9
(-23.9 to 47.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Bicarbonate, Placebo
Comments The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -32.5
Confidence Interval (2-Sided) 95%
-56.3 to 4.2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Urinary Levels of Fibronectin
Hide Description Fibronectin is a marker of kidney injury.
Time Frame The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Bicarbonate Placebo
Hide Arm/Group Description:
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months.
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
Overall Number of Participants Analyzed 35 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent change
8.8
(-9.4 to 30.7)
1.1
(-15.8 to 21.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Bicarbonate, Placebo
Comments The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.7
Confidence Interval (2-Sided) 95%
-15.1 to 36.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Urinary Albumin Levels
Hide Description Urinary albumin is a marker of kidney damage
Time Frame The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Bicarbonate Placebo
Hide Arm/Group Description:
Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
Overall Number of Participants Analyzed 35 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent change
21.1
(-3.1 to 51.3)
11.9
(-10.5 to 39.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Bicarbonate, Placebo
Comments The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-24.6 to 35.9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Estimated Glomerular Filtration (eGFR)
Hide Description eGFR is a measure of kidney function
Time Frame The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Bicarbonate Placebo
Hide Arm/Group Description:
Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
Overall Number of Participants Analyzed 35 39
Mean (95% Confidence Interval)
Unit of Measure: ml/min per 1.73m2
1.96
(-0.47 to 4.40)
-1.41
(-3.80 to 0.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Bicarbonate, Placebo
Comments The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.37
Confidence Interval (2-Sided) 95%
-0.05 to 6.79
Estimation Comments [Not Specified]
Time Frame Adverse event data were collected during each participant's 6-month follow-up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sodium Bicarbonate Placebo
Hide Arm/Group Description Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses. Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
All-Cause Mortality
Sodium Bicarbonate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/39 (0.00%) 
Hide Serious Adverse Events
Sodium Bicarbonate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/39 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sodium Bicarbonate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/39 (0.00%) 
Change in urinary levels of Bb and membrane attack complex (MAC) were initial secondary outcomes. However, we had difficulty measuring these. Many subjects could not complete the physical activity assessment, which was an initial secondary outcome.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kalani Raphael, Principal Investigator
Organization: VA Salt Lake City Healthcare System
Phone: 801-582-1565 ext 1794
EMail: kalani.raphael@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01574157    
Other Study ID Numbers: CLIN-002-11F
First Submitted: March 27, 2012
First Posted: April 10, 2012
Results First Submitted: June 26, 2019
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019