Trial Outcomes & Findings for Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants (NCT NCT02092857)
NCT ID: NCT02092857
Last Updated: 2014-04-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
89 participants
Primary outcome timeframe
10 weeks
Results posted on
2014-04-25
Participant Flow
Participant milestones
| Measure |
34 mg/100 kcal Arachidonic Acid
10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
|
25 mg/100 kcal Arachidonic Acid
10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
|
Infant Formula Without Arachidonic Acid
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
29
|
|
Overall Study
COMPLETED
|
20
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
Baseline characteristics by cohort
| Measure |
34 mg/100 kcal Arachidonic Acid
n=30 Participants
10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
|
25 mg/100 kcal Arachidonic Acid
n=30 Participants
10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
|
Infant Formula Without Arachidonic Acid
n=29 Participants
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
16.8 days
STANDARD_DEVIATION 3.8 • n=99 Participants
|
16.5 days
STANDARD_DEVIATION 3.8 • n=107 Participants
|
17.8 days
STANDARD_DEVIATION 4.4 • n=206 Participants
|
17 days
STANDARD_DEVIATION 1.2 • n=157 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
48 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
41 Participants
n=157 Participants
|
|
Region of Enrollment
Canada
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
29 participants
n=206 Participants
|
89 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: 10 weeksOutcome measures
| Measure |
34 mg/100 kcal Arachidonic Acid
n=13 Participants
10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
|
25 mg/100 kcal Arachidonic Acid
n=12 Participants
10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
|
Infant Formula Without Arachidonic Acid
n=9 Participants
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
|
|---|---|---|---|
|
Number of Antigen-presenting B Cells
|
21.9 percentage of CD20+ B cells
|
22.8 percentage of CD20+ B cells
|
25.1 percentage of CD20+ B cells
|
Adverse Events
34 mg/100 kcal Arachidonic Acid
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
25 mg/100 kcal Arachidonic Acid
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Infant Formula Without Arachidonic Acid
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
34 mg/100 kcal Arachidonic Acid
n=30 participants at risk
10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
|
25 mg/100 kcal Arachidonic Acid
n=30 participants at risk
10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
|
Infant Formula Without Arachidonic Acid
n=29 participants at risk
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
|
|---|---|---|---|
|
General disorders
sudden unexpected infant death
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/29
|
Other adverse events
| Measure |
34 mg/100 kcal Arachidonic Acid
n=30 participants at risk
10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
|
25 mg/100 kcal Arachidonic Acid
n=30 participants at risk
10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
|
Infant Formula Without Arachidonic Acid
n=29 participants at risk
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
|
|---|---|---|---|
|
Ear and labyrinth disorders
swallowing disorder
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
0.00%
0/29
|
|
Gastrointestinal disorders
gastroesophageal reflux
|
3.3%
1/30 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
colic
|
0.00%
0/30
|
6.7%
2/30 • Number of events 2
|
0.00%
0/29
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/30
|
0.00%
0/30
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
cow's milk intolerance
|
0.00%
0/30
|
0.00%
0/30
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
eczema
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash
|
3.3%
1/30 • Number of events 1
|
0.00%
0/30
|
0.00%
0/29
|
|
Renal and urinary disorders
inguinal hernia - male
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
0.00%
0/29
|
|
Renal and urinary disorders
other
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
0.00%
0/29
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place