Trial Outcomes & Findings for DHA Supplementation for Lactating Mothers (NCT NCT01732874)
NCT ID: NCT01732874
Last Updated: 2021-01-05
Results Overview
The study was powered to detect differences in sRAGE levels in infant serum samples at 4 weeks of age from mothers supplemented with 200 or 1000 mg/kg per day of DHA. Serum Soluble Receptor for AGE (sRAGE) levels range from 7300-100 pg/mL where the higher number means a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
value at week 4
Results posted on
2021-01-05
Participant Flow
Mothers recruited at The University of Cincinnati with pregnancy \< 28 weeks and no congenital anomalies
Participant milestones
| Measure |
Expecta 200 mg
Breastfeeding mothers of pre-mature infants randomly assigned to 200 mg Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Expecta 200 mg: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
|
Expecta 1 Gram
Breastfeeding mothers of pre-mature infants randomly assigned to one Gram of Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Expecta 1 gram: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 1 gram of Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
11
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
Expecta 200 mg
Breastfeeding mothers of pre-mature infants randomly assigned to 200 mg Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Expecta 200 mg: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
|
Expecta 1 Gram
Breastfeeding mothers of pre-mature infants randomly assigned to one Gram of Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Expecta 1 gram: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 1 gram of Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Death of Infant
|
3
|
2
|
Baseline Characteristics
DHA Supplementation for Lactating Mothers
Baseline characteristics by cohort
| Measure |
Expecta 200 mg
n=16 Participants
Breastfeeding mothers of pre-mature infants randomly assigned to 200 mg Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Expecta 200 mg: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
|
Expecta 1 Gram
n=11 Participants
Breastfeeding mothers of pre-mature infants randomly assigned to one Gram of Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Expecta 1 gram: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 1 gram of Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Baseline Infant Serum Soluble Receptor for AGE (sRAGE) levels
|
746 pg/ml
n=5 Participants
|
5336 pg/ml
n=7 Participants
|
3041 pg/ml
n=5 Participants
|
PRIMARY outcome
Timeframe: value at week 4Population: Lactating mothers of pre-mature infants
The study was powered to detect differences in sRAGE levels in infant serum samples at 4 weeks of age from mothers supplemented with 200 or 1000 mg/kg per day of DHA. Serum Soluble Receptor for AGE (sRAGE) levels range from 7300-100 pg/mL where the higher number means a worse outcome.
Outcome measures
| Measure |
Expecta 200 mg
n=16 Participants
Breastfeeding mothers of pre-mature infants randomly assigned to 200 mg Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Expecta 200 mg: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
|
Expecta 1 Gram
n=11 Participants
Breastfeeding mothers of pre-mature infants randomly assigned to one Gram of Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Expecta 1 gram: Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 1 gram of Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
|
|---|---|---|
|
Infant Serum Soluble Receptor for AGE (sRAGE) Levels at 4 Weeks From Baseline From Mothers Supplemented With 200 or 1000 mg/kg Per Day of DHA
|
900 pg/mL
Interval 218.0 to 1650.0
|
1127 pg/mL
Interval 256.0 to 2050.0
|
Adverse Events
Expecta 200 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Expecta 1 Gram
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
Dr. Christina J. Valentine MD,MS,RD
Nationwide Childrens Hospital
Phone: (614) 722-2000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place