Trial Outcomes & Findings for Effect of Omega-3 Supplementation During Pregnancy on Regulation of Stress (NCT NCT01158976)

NCT ID: NCT01158976

Last Updated: 2018-05-30

Results Overview

Maternal stress regulation at 30 weeks gestation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: Baseline (pre-stressor)
• Results posted on: 2018-05-30

Participant Flow

Participant milestones

Measure	DHA Supplementation Docosahexanoic Acid (DHA): 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil Placebo: soybean oils with strawberry flavoring
Overall Study STARTED	43	21
Overall Study COMPLETED	34	17
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Omega-3 Supplementation During Pregnancy on Regulation of Stress

Baseline characteristics by cohort

Measure	DHA Supplementation n=43 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=21 Participants Placebo: soybean oils with strawberry flavoring	Total n=64 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	43 Participants n=5 Participants	21 Participants n=7 Participants	64 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	43 Participants n=5 Participants	21 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	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	43 Participants n=5 Participants	21 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	21 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-stressor)

Population: The analysis population reflects those participants who received treatment and with available data for the cortisol assessment

Maternal stress regulation at 30 weeks gestation

Outcome measures

Measure	DHA Supplementation n=33 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=17 Participants Placebo: soybean oils with strawberry flavoring
Maternal Cortisol Levels	0.28 ug/dL Standard Deviation 0.20	0.34 ug/dL Standard Deviation 0.12

PRIMARY outcome

Timeframe: 20 minutes post-stressor

Population: The analysis population reflects those participants who received treatment and with available data for the cortisol assessment

Maternal stress regulation at 30 weeks gestation

Outcome measures

Measure	DHA Supplementation n=33 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=17 Participants Placebo: soybean oils with strawberry flavoring
Maternal Cortisol Levels	0.29 ug/dL Standard Deviation 0.12	0.24 ug/dL Standard Deviation 0.12

PRIMARY outcome

Timeframe: 45 minutes post stressor

Population: The analysis population reflects those participants who received treatment and with available data for the cortisol assessment

Maternal stress regulation at 30 weeks gestation

Outcome measures

Measure	DHA Supplementation n=33 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=17 Participants Placebo: soybean oils with strawberry flavoring
Maternal Cortisol Levels	0.22 ug/dL Standard Deviation 0.10	0.23 ug/dL Standard Deviation 0.14

PRIMARY outcome

Timeframe: 4 months post-partum

Population: The analysis population reflects those infants whose mothers who received treatment and with available data for the cortisol assessment

Infant cortisol response to the Still-Face paradigm before stressor

Outcome measures

Measure	DHA Supplementation n=34 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=15 Participants Placebo: soybean oils with strawberry flavoring
Infant Cortisol Levels	0.23 ug/dL Standard Deviation 0.23	0.29 ug/dL Standard Deviation 0.28

PRIMARY outcome

Timeframe: 4 months post-partum

Population: The analysis population reflects those infants whose mothers who received treatment and with available data for the cortisol assessment

Infant cortisol response to the Still-Face paradigm 20 minutes post-stressor

Outcome measures

Measure	DHA Supplementation n=38 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=17 Participants Placebo: soybean oils with strawberry flavoring
Infant Cortisol Levels	0.22 ug/dL Standard Deviation 0.15	0.32 ug/dL Standard Deviation 0.27

PRIMARY outcome

Timeframe: 4 months post-partum

Population: The analysis population reflects those infants whose mothers who received treatment and with available data for the cortisol assessment

Infant cortisol response to the Still-Face paradigm 45 mins post-stressor

Outcome measures

Measure	DHA Supplementation n=38 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=17 Participants Placebo: soybean oils with strawberry flavoring
Infant Cortisol Levels	0.21 ug/dL Standard Deviation 0.17	0.31 ug/dL Standard Deviation 0.20

SECONDARY outcome

Timeframe: 16-21 weeks gestation

Population: The analysis population reflects those participants who received treatment and with available data for the assessment

Maternal depression symptoms at 16 to 24 weeks gestation, as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.

Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.

Outcome measures

Measure	DHA Supplementation n=43 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=20 Participants Placebo: soybean oils with strawberry flavoring
Maternal Depression Symptoms	13.05 units on a scale Standard Deviation 5.3	12.80 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 24 weeks

Population: The analysis population reflects those participants who received treatment and with available data for the assessment

Maternal depression symptoms at 24 weeks gestation as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.

Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.

Outcome measures

Measure	DHA Supplementation n=35 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=18 Participants Placebo: soybean oils with strawberry flavoring
Maternal Depression Symptoms	13.3 units on a scale Standard Deviation 5.1	12.11 units on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: 30 weeks gestation

Population: The analysis population reflects those participants who received treatment and with available data for the assessment

Maternal depression symptoms at 30 weeks gestation, as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.

Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.

Outcome measures

Measure	DHA Supplementation n=34 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=17 Participants Placebo: soybean oils with strawberry flavoring
Maternal Depression Symptoms	12.12 units on a scale Standard Deviation 4.8	11.35 units on a scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline: 16 - 21 weeks

Population: The analysis population reflects those participants who received treatment and with available data for the assessment

Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at baseline. There are 10 questions in this scale and they all refer to typical life stressors.

Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

• Scores ranging from 0-13 would be considered low stress.
• Scores ranging from 14-26 would be considered moderate stress.
• Scores ranging from 27-40 would be considered high perceived stress

Outcome measures

Measure	DHA Supplementation n=43 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=20 Participants Placebo: soybean oils with strawberry flavoring
Maternal Perceived Stress Scale (PSS) Score	27.77 units on a scale Standard Deviation 2.2	29 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 24 weeks gestation

Population: The analysis population reflects those participants who received treatment and with available data for the assessment

Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at 24 weeks gestation.

There are 10 questions in this scale and they all refer to typical life stressors.

Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

• Scores ranging from 0-13 would be considered low stress.
• Scores ranging from 14-26 would be considered moderate stress.
• Scores ranging from 27-40 would be considered high perceived stress

Outcome measures

Measure	DHA Supplementation n=35 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=18 Participants Placebo: soybean oils with strawberry flavoring
Maternal Perceived Stress Scale Score	28.06 units on a scale Standard Deviation 3.5	27.72 units on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 30 weeks gestation

Population: The analysis population reflects those participants who received treatment and with available data for the assessment

Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at 30 weeks gestation.

There are 10 questions in this scale and they all refer to typical life stressors.

Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

• Scores ranging from 0-13 would be considered low stress.
• Scores ranging from 14-26 would be considered moderate stress.
• Scores ranging from 27-40 would be considered high perceived stress

Outcome measures

Measure	DHA Supplementation n=34 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=17 Participants Placebo: soybean oils with strawberry flavoring
Maternal Perceived Stress Scale Score	27.47 units on a scale Standard Deviation 3.4	29.29 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Time of birth, total sample range: 27.60 to 41.60 weeks gestation

Population: The analysis population reflects those infants of participants who received treatment and with available data for the assessment

Weight of infant

Outcome measures

Measure	DHA Supplementation n=34 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=15 Participants Placebo: soybean oils with strawberry flavoring
Infant Birth Weight	3074.39 grams Standard Deviation 582.34	2919.56 grams Standard Deviation 537.74

SECONDARY outcome

Timeframe: Time of birth, total sample range: 27.60 to 41.60 weeks gestation

Population: The analysis population reflects those infants of participants who received treatment and with available data for the assessment

Percentage of infants who had a 1-minute Apgar scores of 9 Sub scores from 5 categories( Breathing effort, Heart rate, Muscle tone, Reflexes, Skin color) are added together Score range: 1-10 A higher score is better where 7,8,9 are normal

Outcome measures

Measure	DHA Supplementation n=34 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=15 Participants Placebo: soybean oils with strawberry flavoring
Percentage of Infants Who Had a 1-minute Apgar Scores of 9	75.8 percentage of infants	59.1 percentage of infants

SECONDARY outcome

Timeframe: Time of birth, total sample range: 27.60 to 41.60 weeks gestation

Population: The analysis population reflects those infants of participants who received treatment and with available data for the assessment

Gestational Age at time of birth Total sample range: 27.60 to 41.60 weeks Below 37 considered premature Mothers typically induced after 41 weeks due to increased pregnancy risks after this time

Outcome measures

Measure	DHA Supplementation n=34 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=15 Participants Placebo: soybean oils with strawberry flavoring
Gestational Age (GA)	38.85 Weeks Standard Deviation 2	38.84 Weeks Standard Deviation 2.06

SECONDARY outcome

Timeframe: 3 months old

Scaled Score on Receptive Communication subscale of Bayley Scale for Infant Development that determines how well a child recognizes sounds and how much a child understands spoken words and directions compared to a group of children within the same age range from across the United States. Subscale consists of 49 items. Child'e scaled score is calculated from total raw scores.

Scaled score range: 1 - 12 Lower scores indicate more developmental delay.

Outcome measures

Measure	DHA Supplementation n=34 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=15 Participants Placebo: soybean oils with strawberry flavoring
Infant's Receptive Communication Scaled Score	4.88 units on a scale Standard Deviation 2.66	4.33 units on a scale Standard Deviation 1.91

SECONDARY outcome

Timeframe: At approximately 3 months of age

Population: The analysis population reflects those infants of participants who received treatment and with available data for the assessment

Scaled Score for Expressive Communication subscale of Bayley Scale for Infant Development that determines how well a child recognizes sounds and how much a child communicates using sounds, gestures, or words compared to a group of children within the same age range from across the United States. Subscale consists of 48 items. Child'e scaled score is calculated from total raw scores.

Scaled score range: 2 - 9 Lower scores indicate more developmental delay.

Outcome measures

Measure	DHA Supplementation n=34 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=15 Participants Placebo: soybean oils with strawberry flavoring
Infant's Expressive Communication Scaled Score	6.21 units on a scale Standard Deviation 1.41	6.00 units on a scale Standard Deviation 1.89

SECONDARY outcome

Timeframe: Approximately 3 months of age

Population: The analysis population reflects those infants of participants who received treatment and with available data for the assessment

Fine motor skills subscale score from Bayley Scale for Infant Development. Determines how well a child recognizes sounds and how much a child can use his or her hands and fingers to do things compared to a group of children within the same age range from across the United States. Subscale consists of 66 items. Child's scaled score is calculated from total raw scores.

Scaled score range: 1 - 8 Lower scores indicate more developmental delay.

Outcome measures

Measure	DHA Supplementation n=34 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=15 Participants Placebo: soybean oils with strawberry flavoring
Infant's Fine Motor Skills Scaled Score	2.38 units on a scale Standard Deviation 1.88	2.33 units on a scale Standard Deviation 2.13

SECONDARY outcome

Timeframe: Approximately 3 months of age

Population: The analysis population reflects those infants of participants who received treatment and with available data for the assessment

Infants Gross Motor skills subscale score from Bayley Scale for Infant Development. Determines how well a child well your child can move his or her body compared to a group of children within the same age range from across the United States. Subscale consists of 72 items. Child's scaled score is calculated from total raw scores.

Scaled score range: 1 - 6 'Lower scores indicate more developmental delay.

Outcome measures

Measure	DHA Supplementation n=34 Participants Docosahexanoic Acid: 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery	Soybean Oil n=15 Participants Placebo: soybean oils with strawberry flavoring
Infant's Gross Motor Skills Scaled Score	1.65 units on a scale Standard Deviation 1.20	1.60 units on a scale Standard Deviation 1.12

Adverse Events

DHA Supplementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Soybean Oil

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

Kathry Keenan

University of Chicago

Phone: 773-702-4449

Email: kekeenan@uchicago.edu

Results disclosure agreements

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