Trial Outcomes & Findings for Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults (NCT NCT00357214)

NCT ID: NCT00357214

Last Updated: 2020-02-17

Results Overview

Change in 24-hr urinary N-telopeptide/creatinine measured at baseline and 3 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 171 participants
• Primary outcome timeframe: 3 month change in 24-hr urine values
• Results posted on: 2020-02-17

Participant Flow

Participant milestones

Measure	Potassium Bicarbonate Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Potassium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Sodium Bicarbonate Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Sodium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Potassium Chloride Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Microcrystalline Cellulose Participants will receive placebo is microcrystalline cellulose. This compound has no other name. placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water
Overall Study STARTED	43	43	42	43
Overall Study COMPLETED	39	39	42	42
Overall Study NOT COMPLETED	4	4	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Potassium Bicarbonate n=43 Participants Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Potassium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Sodium Bicarbonate n=43 Participants Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Sodium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Potassium Chloride n=42 Participants Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Microcrystalline Cellulose n=43 Participants Participants will receive placebo is microcrystalline cellulose. This compound has no other name. placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water	Total n=171 Participants Total of all reporting groups
Region of Enrollment United States	43 participants n=43 Participants	43 participants n=43 Participants	42 participants n=42 Participants	43 participants n=43 Participants	171 participants n=171 Participants
Age, Customized participant age	62.2 years STANDARD_DEVIATION 7.6 • n=43 Participants	62.6 years STANDARD_DEVIATION 7.6 • n=43 Participants	63.4 years STANDARD_DEVIATION 7.7 • n=42 Participants	63.3 years STANDARD_DEVIATION 7.7 • n=43 Participants	62.9 years STANDARD_DEVIATION 7.7 • n=171 Participants
Sex: Female, Male Female	24 Participants n=43 Participants	24 Participants n=43 Participants	24 Participants n=42 Participants	25 Participants n=43 Participants	97 Participants n=171 Participants
Sex: Female, Male Male	19 Participants n=43 Participants	19 Participants n=43 Participants	18 Participants n=42 Participants	18 Participants n=43 Participants	74 Participants n=171 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 3 month change in 24-hr urine values

Change in 24-hr urinary N-telopeptide/creatinine measured at baseline and 3 months

Outcome measures

Measure	Potassium Bicarbonate n=39 Participants Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Potassium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Sodium Bicarbonate n=39 Participants Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Sodium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Potassium Chloride n=42 Participants Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Microcrystalline Cellulose n=42 Participants Participants will receive placebo is microcrystalline cellulose. This compound has no other name. placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water
Biochemical Markers of Bone Turnover	-6.25 nmol/mmol Standard Error 1.75	-3.36 nmol/mmol Standard Error 1.68	-0.14 nmol/mmol Standard Error 1.71	0.5 nmol/mmol Standard Error 1.61

Adverse Events

Potassium Bicarbonate

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sodium Bicarbonate

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Potassium Chloride

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Microcrystalline Cellulose

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Potassium Bicarbonate n=43 participants at risk Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Potassium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Sodium Bicarbonate n=43 participants at risk Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Sodium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Potassium Chloride n=42 participants at risk Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water	Microcrystalline Cellulose n=43 participants at risk Participants will receive placebo is microcrystalline cellulose. This compound has no other name. placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water
Gastrointestinal disorders gastrointestinal symptoms	2.3% 1/43 • Number of events 1	7.0% 3/43 • Number of events 3	16.7% 7/42 • Number of events 7	2.3% 1/43 • Number of events 1

Additional Information

Bess Dawson-Hughes

Tufts University

Phone: 617 556 3066

Email: bess.dawson-hughes@tufts.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place