Healthy Pregnant WomenNAPSNCT01158976
Effect of Omega-3 Supplementation During Pregnancy on Regulation of Stress
A study testing Docosahexanoic Acid in people with Healthy Pregnant Women, run by University of Chicago at 2 sites in United States.
Trial summary
This will be the first study of the effect of essential fatty acid supplementation in pregnant women living in inner-city poverty on the stress response system during pregnancy. The investigators proposed that essential fatty acid supplementation will be associated with reductions in the experience of stress, more… Read more about this study
- Who is it for?
- Ages 20 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Pregnant Women
- What is being tested?
- Docosahexanoic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- African American race
- age between 20 and 34 years
- 16-21 weeks gestation
- household receipt of public assistance (e.g., Medicaid insurance) due to -low-income
- low levels of DHA consumption as defined as less than two fish servings per week.
Who cannot join
- known medical complications (e.g., gestational diabetes, pre-eclampsia), -regular use of steroid medications
- alcohol use
- cigarettes or use of illegal substances (by maternal report)
- use of blood thinners or anti-coagulants
- use of psychotropic medications
- Body Mass Index >40
- allergy to iodine and/or soy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago
Chicago, Illinois, 60637
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Impact of Omega-3 Intake During Pregnancy on Maternal Stress and Infant Outcome
This will be the first study of the effect of essential fatty acid supplementation in pregnant women living in inner-city poverty on the stress response system during pregnancy. The investigators proposed that essential fatty acid supplementation will be associated with reductions in the experience of stress, more modulated hormonal response to stress, and more optimal regulation of emotion and attention in the infant, even within the context inner-city poverty.
Read the detailed description
Significance: Pregnant women living in poverty often experience chronic stress, and consequently higher levels of stress hormones. In utero exposure to high levels of stress hormones can negatively affect the developing fetus and later, the infant's capacity for emotion and behavioral regulation. In this proposal we describe a developing program of research designed to reduce the negative impact of prenatal stress on infant health and development via nutritional supplementation of docosahexaenoic acid (DHA) during pregnancy. DHA is a long-chain polyunsaturated fatty acid member of the omega-3 fatty acid family. DHA is found in its highest concentrations in neural cell membranes, affecting receptor function, neurotransmitter uptake, and signal transmission. There is growing evidence that low levels of dietary DHA intake are associated with suboptimal response to stress and that DHA supplementation can modulate stress response. Aims: The goals of the proposed study are to explore whether DHA supplementation during pregnancy is associated with 1) a reduction in maternal perceived stress during pregnancy; 2) a more modulated maternal cortisol response to a stress stimulus during pregnancy, and 3) more optimal regulation of emotion and behavior in the infant. Approach: Sixty-five pregnant women living in inner-city poverty, who consume less than two servings of fish per week, will be randomly assigned to receive 450 mg/daily of DHA or placebo beginning at 16-20 weeks gestation through the end of pregnancy. Perceived stress, pregnancy related stress, stressful life events, anxiety, and depression will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy and at 4 months post-partum. DHA levels will be assessed at baseline and at 36 weeks of pregnancy. Cortisol response to the Trier Social Stress Test will be measured at baseline, 24, and 30 weeks. At 4 months post-partum infant temperament, cognitive development and stress reactivity will be assessed in the laboratory. Investigators: This proposal stems from an National Institute of Mental Health R21 Translational Science Network on prenatal stress and mental health outcomes in the offspring. Three members of that network, Drs. Keenan, Carter, and Glover, are all funded investigators in the area of prenatal stress and child mental health, which is a prioritized area of exploratory research that could directly impact clinical care. They are collaborating on the present application. Innovation: This will be the first randomized controlled study of the effect of DHA supplementation on stress response in pregnant women living in inner-city poverty, and the first study of maternal DHA supplementation on emotion and stress regulation in their infants. Relevance: If DHA supplementation is associated with reductions in perceived stress, more modulated maternal cortisol response to stress, and more optimal emotional and behavioral regulation in the infant, even within the context inner-city poverty, then a comprehensive program of research on the mechanisms by which these associations evolve and the potential for broad-based prevention of poor developmental outcomes among children born to women living in poverty can be launched.
- Conditions
- Healthy Pregnant Women
- Being tested
- Docosahexanoic Acid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexanoic AcidDietary supplement
Also called Nordic Naturals ProDHA
450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
PlaceboOther
soybean oils with strawberry flavoring
| Study group | Role | What they receive |
|---|---|---|
| DHA supplementation | Experimental | Not described Receives: Dietary Supplement: Docosahexanoic Acid |
| Soybean Oil | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Cortisol Levels
Maternal stress regulation at 30 weeks gestation
Measured: Baseline (pre-stressor)
Maternal Cortisol Levels
Maternal stress regulation at 30 weeks gestation
Measured: 20 minutes post-stressor
Maternal Cortisol Levels
Maternal stress regulation at 30 weeks gestation
Measured: 45 minutes post stressor
Infant Cortisol Levels
Infant cortisol response to the Still-Face paradigm before stressor
Measured: 4 months post-partum
Infant Cortisol Levels
Infant cortisol response to the Still-Face paradigm 20 minutes post-stressor
Measured: 4 months post-partum
Infant Cortisol Levels
Infant cortisol response to the Still-Face paradigm 45 mins post-stressor
Measured: 4 months post-partum
Secondary outcomes (13)
Maternal Depression Symptoms
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.
Measured: 16-21 weeks gestation
Maternal Depression Symptoms
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.
Measured: 24 weeks
Maternal Depression Symptoms
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.
Measured: 30 weeks gestation
Maternal Perceived Stress Scale (PSS) Score
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
Measured: Baseline: 16 - 21 weeks
Maternal Perceived Stress Scale Score
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
Measured: 24 weeks gestation
Maternal Perceived Stress Scale Score
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
Measured: 30 weeks gestation
Infant Birth Weight
Weight of infant
Measured: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
Percentage of Infants Who Had a 1-minute Apgar Scores of 9
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
Measured: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
Gestational Age (GA)
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
Measured: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
Infant's Receptive Communication Scaled Score
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.
Measured: 3 months old
Infant's Expressive Communication Scaled Score
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.
Measured: At approximately 3 months of age
Infant's Fine Motor Skills Scaled Score
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.
Measured: Approximately 3 months of age
Infant's Gross Motor Skills Scaled Score
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.
Measured: Approximately 3 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Pregnant WomenStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158976
- Sponsor's protocol ID
- 09-190A
- Other IDs
- R21HD058269
- Acronym
- NAPS
- Status last verified
- Apr 2018
- First submitted
- 28 Jun 2010
- Last updated
- 30 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Keenan K, Hipwell AE, Bortner J, Hoffmann A, McAloon R. Association between fatty acid supplementation and prenatal stress in African Americans: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1080-1087. doi: 10.1097/AOG.0000000000000559.
PubMed 25415158
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Omega-3 Intake During Pregnancy on Maternal Stress and Infant Outcome
- ClinicalTrials.gov ID
- NCT01158976
- Acronym / sponsor ID
- NAPS / 09-190A
- Conditions
- Healthy Pregnant Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Posted 30 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be the first study of the effect of essential fatty acid supplementation in pregnant women living in inner-city poverty on the stress response system during pregnancy. The investigators proposed that essential fatty acid supplementation will be associated with reductions in the experience of stress, more modulated hormonal response to stress, and more optimal regulation of emotion and attention in the infant, even within the context inner-city poverty.
Detailed description
Significance: Pregnant women living in poverty often experience chronic stress, and consequently higher levels of stress hormones. In utero exposure to high levels of stress hormones can negatively affect the developing fetus and later, the infant's capacity for emotion and behavioral regulation. In this proposal we describe a developing program of research designed to reduce the negative impact of prenatal stress on infant health and development via nutritional supplementation of docosahexaenoic acid (DHA) during pregnancy. DHA is a long-chain polyunsaturated fatty acid member of the omega-3 fatty acid family. DHA is found in its highest concentrations in neural cell membranes, affecting receptor function, neurotransmitter uptake, and signal transmission. There is growing evidence that low levels of dietary DHA intake are associated with suboptimal response to stress and that DHA supplementation can modulate stress response. Aims: The goals of the proposed study are to explore whether DHA supplementation during pregnancy is associated with 1) a reduction in maternal perceived stress during pregnancy; 2) a more modulated maternal cortisol response to a stress stimulus during pregnancy, and 3) more optimal regulation of emotion and behavior in the infant. Approach: Sixty-five pregnant women living in inner-city poverty, who consume less than two servings of fish per week, will be randomly assigned to receive 450 mg/daily of DHA or placebo beginning at 16-20 weeks gestation through the end of pregnancy. Perceived stress, pregnancy related stress, stressful life events, anxiety, and depression will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy and at 4 months post-partum. DHA levels will be assessed at baseline and at 36 weeks of pregnancy. Cortisol response to the Trier Social Stress Test will be measured at baseline, 24, and 30 weeks. At 4 months post-partum infant temperament, cognitive development and stress reactivity will be assessed in the laboratory. Investigators: This proposal stems from an National Institute of Mental Health R21 Translational Science Network on prenatal stress and mental health outcomes in the offspring. Three members of that network, Drs. Keenan, Carter, and Glover, are all funded investigators in the area of prenatal stress and child mental health, which is a prioritized area of exploratory research that could directly impact clinical care. They are collaborating on the present application. Innovation: This will be the first randomized controlled study of the effect of DHA supplementation on stress response in pregnant women living in inner-city poverty, and the first study of maternal DHA supplementation on emotion and stress regulation in their infants. Relevance: If DHA supplementation is associated with reductions in perceived stress, more modulated maternal cortisol response to stress, and more optimal emotional and behavioral regulation in the infant, even within the context inner-city poverty, then a comprehensive program of research on the mechanisms by which these associations evolve and the potential for broad-based prevention of poor developmental outcomes among children born to women living in poverty can be launched.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA supplementation | Experimental | Dietary Supplement: Docosahexanoic Acid |
| Soybean Oil | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- African American race
- age between 20 and 34 years
- 16-21 weeks gestation
- household receipt of public assistance (e.g., Medicaid insurance) due to -low-income
- low levels of DHA consumption as defined as less than two fish servings per week.
Key exclusion criteria (7 listed)
- known medical complications (e.g., gestational diabetes, pre-eclampsia), -regular use of steroid medications
- alcohol use
- cigarettes or use of illegal substances (by maternal report)
- use of blood thinners or anti-coagulants
- use of psychotropic medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docosahexanoic AcidAlso: Nordic Naturals ProDHA450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery | Dietary supplement | DHA supplementation |
| Placebosoybean oils with strawberry flavoring | Other | Soybean Oil |
Primary outcome
Maternal Cortisol Levels
Time frame: Baseline (pre-stressor)
Maternal stress regulation at 30 weeks gestation
Maternal Cortisol Levels
Time frame: 20 minutes post-stressor
Maternal stress regulation at 30 weeks gestation
Maternal Cortisol Levels
Time frame: 45 minutes post stressor
Maternal stress regulation at 30 weeks gestation
Infant Cortisol Levels
Time frame: 4 months post-partum
Infant cortisol response to the Still-Face paradigm before stressor
Infant Cortisol Levels
Time frame: 4 months post-partum
Infant cortisol response to the Still-Face paradigm 20 minutes post-stressor
Infant Cortisol Levels
Time frame: 4 months post-partum
Infant cortisol response to the Still-Face paradigm 45 mins post-stressor
13 secondary outcomes
Maternal Depression Symptoms
Time frame: 16-21 weeks gestation
Maternal Depression Symptoms
Time frame: 24 weeks
Maternal Depression Symptoms
Time frame: 30 weeks gestation
Maternal Perceived Stress Scale (PSS) Score
Time frame: Baseline: 16 - 21 weeks
Maternal Perceived Stress Scale Score
Time frame: 24 weeks gestation
Maternal Perceived Stress Scale Score
Time frame: 30 weeks gestation
Infant Birth Weight
Time frame: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
Percentage of Infants Who Had a 1-minute Apgar Scores of 9
Time frame: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
Gestational Age (GA)
Time frame: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
Infant's Receptive Communication Scaled Score
Time frame: 3 months old
Infant's Expressive Communication Scaled Score
Time frame: At approximately 3 months of age
Infant's Fine Motor Skills Scaled Score
Time frame: Approximately 3 months of age
Infant's Gross Motor Skills Scaled Score
Time frame: Approximately 3 months of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25415158Keenan K, Hipwell AE, Bortner J, Hoffmann A, McAloon R. Association between fatty acid supplementation and prenatal stress in African Americans: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1080-1087. doi: 10.1097/AOG.0000000000000559.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docosahexanoic Acid in people with Healthy Pregnant Women, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Cortisol Levels (time frame: Baseline (pre-stressor)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.