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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD084586 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of Pittsburgh | OTHER |
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The purpose of the study is to test whether nutritional supplementation during pregnancy is associated with 1) improved maternal health during pregnancy; 2) improved infant birth and neurodevelopmental outcomes, and 3) whether the association between nutritional supplementation during pregnancy and infant outcomes is partially mediated by reductions in maternal perceived stress and stress reactivity during pregnancy.
Low-income pregnant women 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 the infant's capacity for emotion and behavioral regulation. This program of research is 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.
One hundred sixty-two pregnant women will be randomly assigned to receive 450 mg/daily of DHA or placebo beginning at 9-12 weeks of gestation through the end of pregnancy. Perceived stress, stressful life events, anxiety, and depression, inflammatory markers, DHA levels and response to a laboratory stressor will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy. Neonatal outcomes (e.g., gestational age, birth weight, delivery complications) will be collected from medical records, and infant neurodevelopmental outcomes and stress reactivity will be assessed at 1, 4 and 9 months of age. Coded data will be analyzed by the Investigators at University of Chicago and University of Pittsburgh
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral supplement for pregnant women | Experimental | 450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy |
|
| Sugar pill | Placebo Comparator | 450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHA | Dietary Supplement | 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4 | Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress | 16 months |
| Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3 | Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Keenan, Ph.D | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
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Active recruitment from the University of Chicago Medical Center and affiliated Federally Qualified Health Centers (FQHC) occurred between 2016 and 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Supplement for Pregnant Women | 450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy DHA: 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks |
| FG001 | Sugar Pill | 450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy Sugar pill: 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Supplement for Pregnant Women | 450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy DHA: 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks |
| BG001 | Sugar Pill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4 | Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress | Of the 168 participants recruited, 127 had PSS data for all 4 visits. | Posted | Mean | Standard Deviation | change in score on a scale | 16 months |
|
1 year, 8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Supplement for Pregnant Women | 450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy DHA: 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kate Keenan | University of Chicago | 773-702-4449 | kekeenan@uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2014 | Jun 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D000073893 | Sugars |
| D013024 | Soybean Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Sugar pill | Dietary Supplement | 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks |
|
|
450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy Sugar pill: 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Sugar Pill |
450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy Sugar pill: 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks |
|
|
| Primary | Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3 | Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress | Of the 168 participants recruited, 133 had PSS data for visits 1, 2 and 3. | Posted | Mean | Standard Deviation | change in score on a scale | 12 months |
|
|
|
| 0 |
| 112 |
| 0 |
| 112 |
| 0 |
| 112 |
| EG001 | Sugar Pill | 450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy Sugar pill: 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks | 0 | 56 | 0 | 56 | 0 | 56 |
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| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D002241 | Carbohydrates |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |