Musculoskeletal Effects of Bicarbonate

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Bess Dawson-Hughes, Tufts University
ClinicalTrials.gov Identifier:
NCT01475214
First received: November 16, 2011
Last updated: September 18, 2015
Last verified: September 2015
Results First Received: June 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Muscle Loss
Fractures
Osteoporosis, Age Related
Fall Injury
Interventions: Dietary Supplement: potassium bicarbonate
Other: Inactive placebo capsule

  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
Potassium Bicarbonate Low Dose

potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water

potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water

Potassium Bicarbonate Higher Dose

potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water

potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water

Inactive Capsule

microcrystalline cellulose

placebo: microcrystalline cellulose


Participant Flow:   Overall Study
    Potassium Bicarbonate Low Dose     Potassium Bicarbonate Higher Dose     Inactive Capsule  
STARTED     84     79     81  
COMPLETED     79     75     79  
NOT COMPLETED     5     4     2  
Lost to Follow-up                 1                 0                 1  
Physician Decision                 2                 0                 0  
Withdrawal by Subject                 2                 4                 1  



  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
Potassium Bicarbonate Low Dose

potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water

potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water

Potassium Bicarbonate Higher Dose

potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water

potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water

Inactive Placebo Capsule

microcrystalline cellulose

placebo: microcrystalline cellulose

Total Total of all reporting groups

Baseline Measures
    Potassium Bicarbonate Low Dose     Potassium Bicarbonate Higher Dose     Inactive Placebo Capsule     Total  
Number of Participants  
[units: participants]
  84     79     81     244  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     40     40     41     121  
>=65 years     44     39     40     123  
Age  
[units: years]
Mean (Standard Deviation)
  67.4  (5.5)     66.4  (5.1)     66.8  (6.1)     66.9  (5.6)  
Gender  
[units: participants]
       
Female     41     39     38     118  
Male     43     40     43     126  
Race/Ethnicity, Customized  
[units: participants]
       
Caucasian, Non-hispanic     76     68     75     219  
Caucasian, Hispanic     2     1     2     5  
African-American     6     9     3     18  
Asian     0     1     1     2  
Region of Enrollment  
[units: participants]
       
United States     84     79     81     244  
Weight  
[units: kg]
Mean (Standard Deviation)
  74.8  (13.7)     74.2  (13.0)     73.2  (14.0)     74.1  (13.6)  
Glomerular Filtration Rate (GFR)  
[units: ml/min/1.73m^2]
Mean (Standard Deviation)
  76.5  (13.2)     77.5  (12.8)     74.8  (12.9)     76.3  (13.0)  
Serum potassium  
[units: meq/L]
Mean (Standard Deviation)
  4.31  (0.29)     4.39  (0.36)     4.30  (0.31)     4.33  (0.32)  
Serum bicarbonate  
[units: mmol/L]
Mean (Standard Deviation)
  26.1  (1.9)     25.8  (2.4)     26.1  (2.4)     26.0  (2.2)  
Urine calcium/creatinine  
[units: mg/g]
Mean (Standard Deviation)
  99  (43)     99  (48)     114  (69)     104  (55)  



  Outcome Measures
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1.  Primary:   The Dose of Potassium Bicarbonate Needed for Maximal Suppression of 24-hr Urinary N-telopeptide   [ Time Frame: 84 days ]

2.  Primary:   Co-primary Aim - to Identify the Dose of KHCO3 Needed for Maximal Suppression of 24-hr Urinary Nitrogen   [ Time Frame: 84 days ]


  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
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  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. Bess Dawson-Hughes
Organization: Jean Mayer Human Nutrition Research Center on Aging at Tufts University
phone: 617-556-3066
e-mail: bess.dawson-hughes@tufts.edu



Responsible Party: Bess Dawson-Hughes, Tufts University
ClinicalTrials.gov Identifier: NCT01475214     History of Changes
Other Study ID Numbers: 2705
R01AR060261 ( US NIH Grant/Contract Award Number )
RO1AR060261 ( Other Grant/Funding Number: NIAMS )
Study First Received: November 16, 2011
Results First Received: June 10, 2015
Last Updated: September 18, 2015
Health Authority: United States: Federal Government