Trial Outcomes & Findings for Gender Difference in Response to Caffeine in Children and Adolescents (NCT NCT02119416)
NCT ID: NCT02119416
Last Updated: 2022-08-17
Results Overview
Heart rate measurements were taken every 10 minutes, following 1 minute of rest with an automated Welch Allen Blood Pressure Cuff. We have reported the data as the peak heart rate after 2 mg/kg.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
Heart rate was collected every 10 minutes for 60 minutes after the dose of caffeine.
Results posted on
2022-08-17
Participant Flow
Participant milestones
| Measure |
1mg/kg Caffeine
Order of Caffeine Administration for Visits 1-6: 1mg/kg then 2mg/kg then 0mg/kg
|
2mg/kg Caffeine
Order of Caffeine Administration for Visits 1-6: 2mg/kg then 0mg/kg then 1mg/kg
|
Placebo
Order of Administration for Visits 1-6: 0mg/kg then 1mg/kg then 2mg/kg
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
36
|
33
|
|
Overall Study
COMPLETED
|
30
|
35
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
1mg/kg Caffeine
Order of Caffeine Administration for Visits 1-6: 1mg/kg then 2mg/kg then 0mg/kg
|
2mg/kg Caffeine
Order of Caffeine Administration for Visits 1-6: 2mg/kg then 0mg/kg then 1mg/kg
|
Placebo
Order of Administration for Visits 1-6: 0mg/kg then 1mg/kg then 2mg/kg
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
wrong pubertal stage
|
1
|
0
|
1
|
Baseline Characteristics
Gender Difference in Response to Caffeine in Children and Adolescents
Baseline characteristics by cohort
| Measure |
1mg/kg Caffeine
n=30 Participants
Order of Caffeine Administration for Visits 1-6: 1mg/kg then 2mg/kg then 0mg/kg
|
2mg/kg Caffeine
n=35 Participants
Order of Caffeine Administration for Visits 1-6: 2mg/kg then 0mg/kg then 1mg/kg
|
Placebo
n=31 Participants
Order of Administration for Visits 1-6: 0mg/kg then 1mg/kg then 2mg/kg
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
12.2 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
12.2 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
12.2 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
12.2 years
STANDARD_DEVIATION 1.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
35 participants
n=7 Participants
|
31 participants
n=5 Participants
|
96 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Heart rate was collected every 10 minutes for 60 minutes after the dose of caffeine.Heart rate measurements were taken every 10 minutes, following 1 minute of rest with an automated Welch Allen Blood Pressure Cuff. We have reported the data as the peak heart rate after 2 mg/kg.
Outcome measures
| Measure |
1mg/kg Caffeine Then 2 mg/kg Then 0 mg/kg
n=30 Participants
Order of Caffeine Administration for Visits 1-6: 1mg/kg then 2mg/kg then 0mg/kg
|
2mg/kg Caffeine Then 0 mg/kg Then 1 mg/kg
n=35 Participants
Order of Caffeine Administration for Visits 1-6: 2mg/kg then 0mg/kg then 1mg/kg
|
0 mg/kg Then 1 mg/kg Then 2 mg/kg
n=31 Participants
Order of Administration for Visits 1-6: 0mg/kg then 1mg/kg then 2mg/kg
|
|---|---|---|---|
|
Peak Heart Rate After 2 mg/kg of Caffeine
|
73.6 beats per minute
Standard Error 2.32
|
73.2 beats per minute
Standard Error 1.6
|
79.6 beats per minute
Standard Error 2.64
|
PRIMARY outcome
Timeframe: Blood pressure was assessed every 10 minutes for 60 minutes after caffeine was administered.Population: Participants were randomized to a particular order, but this was a crossover design.
Blood pressure measurements were taken every 10 minutes, following 1 minute of rest with an automated Welch Allen Blood Pressure Cuff. We have reported the peak heart rate after the 2 mg/kg dose of caffeine.
Outcome measures
| Measure |
1mg/kg Caffeine Then 2 mg/kg Then 0 mg/kg
n=30 Participants
Order of Caffeine Administration for Visits 1-6: 1mg/kg then 2mg/kg then 0mg/kg
|
2mg/kg Caffeine Then 0 mg/kg Then 1 mg/kg
n=35 Participants
Order of Caffeine Administration for Visits 1-6: 2mg/kg then 0mg/kg then 1mg/kg
|
0 mg/kg Then 1 mg/kg Then 2 mg/kg
n=31 Participants
Order of Administration for Visits 1-6: 0mg/kg then 1mg/kg then 2mg/kg
|
|---|---|---|---|
|
Peak Systolic Blood Pressure
|
107.6 mmHg
Standard Error 1.82
|
112.3 mmHg
Standard Error 1.69
|
109.6 mmHg
Standard Error 2.09
|
Adverse Events
1mg/kg Caffeine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2mg/kg Caffeine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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