Trial Outcomes & Findings for Chronic Versus Acute Dosing of Sodium Citrate for Swimming 200m (NCT NCT01835912)
NCT ID: NCT01835912
Last Updated: 2014-07-24
Results Overview
time to complete 200 metre swimming performances in seconds Participants chose type of swim stroke to swim a maximal effort 200 metre performance
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
once each 200m performance
Results posted on
2014-07-24
Participant Flow
Participant milestones
| Measure |
All Study Participants
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic) and their corresponding placebos.
4 arms: Acute, Acute Placebo, Chronic, Chronic Placebo
Acute: 0.5 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water
Acute Placebo: 500 milliliters of flavoured water
Chronic: 3 days of 0.1 g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water
Chronic Placebo: 3 days of 500 millilitres of flavoured water and 4th day 500 millilitres of flavoured water
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
Acute
|
10
|
|
Overall Study
Acute Placebo
|
10
|
|
Overall Study
Chronic
|
10
|
|
Overall Study
Chronic Placebo
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chronic Versus Acute Dosing of Sodium Citrate for Swimming 200m
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
Acute: dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
Acute Placebo: 500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
Chronic: 3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
Chronic Placebo: 3 days of 500 milliliters flavoured water and the 4th day 500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
|
|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
males
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: once each 200m performancetime to complete 200 metre swimming performances in seconds Participants chose type of swim stroke to swim a maximal effort 200 metre performance
Outcome measures
| Measure |
Flavoured Water Placebo for Acute Dosing
n=10 Participants
500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
|
Sodium Citrate Dihydrate Acute
n=10 Participants
dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
|
Flavoured Water Placebo for Chronic Dosing
n=10 Participants
500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
|
Sodium Citrate Dihydrate Chronic
n=10 Participants
3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
|
|---|---|---|---|---|
|
Time
|
144.2 seconds
Standard Error 4.7
|
145.3 seconds
Standard Error 5.3
|
145.3 seconds
Standard Error 5.4
|
144.8 seconds
Standard Error 5.3
|
SECONDARY outcome
Timeframe: 3 min post performancelactate measured at 3min post trial
Outcome measures
| Measure |
Flavoured Water Placebo for Acute Dosing
n=10 Participants
500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
|
Sodium Citrate Dihydrate Acute
n=10 Participants
dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
|
Flavoured Water Placebo for Chronic Dosing
n=10 Participants
500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
|
Sodium Citrate Dihydrate Chronic
n=10 Participants
3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
|
|---|---|---|---|---|
|
Lactate
|
8.8 mmol/L
Standard Error 0.7
|
10.4 mmol/L
Standard Error 1.3
|
9.5 mmol/L
Standard Error 1.2
|
10.8 mmol/L
Standard Error 1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Rate of Perceived Exertion after each 200m swimming performanceRate of perceived exertion (RPE) was recorded after each 200 metre swimming performance RPE scale is from 6-20. Minimum = 6 (level of exertion equal to lying down) and Maximum = 20 (maximal perceived exertion) Numbers reported are the average of the RPE recorded for all 10 participants.
Outcome measures
| Measure |
Flavoured Water Placebo for Acute Dosing
n=10 Participants
500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
|
Sodium Citrate Dihydrate Acute
n=10 Participants
dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
|
Flavoured Water Placebo for Chronic Dosing
n=10 Participants
500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
|
Sodium Citrate Dihydrate Chronic
n=10 Participants
3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water
Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
|
|---|---|---|---|---|
|
Rate of Perceived Exertion
|
16.4 units on a scale (6-20)
Standard Error 0.6
|
16.1 units on a scale (6-20)
Standard Error 0.6
|
16.6 units on a scale (6-20)
Standard Error 0.3
|
17.1 units on a scale (6-20)
Standard Error 0.6
|
Adverse Events
Flavoured Water Placebo for Acute Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sodium Citrate Dihydrate Acute
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flavoured Water Placebo for Chronic Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sodium Citrate Dihydrate Chronic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place