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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD047315 | 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 |
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The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.
Although numerous trials show benefits of postnatal DHA supplementation for visual acuity and others show benefits for cognitive function and/or attention, studies of increased DHA exposure during fetal life are needed, especially in the US. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHA capsules | Experimental | DHA capsules |
|
| Placebo capsules | Placebo Comparator | Placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHA | Drug | 600 mg DHA |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Total Fatty Acids by Weight | Measure of RBC-phospholipid-DHA at Birth | at time of birth |
| Gestational Age | Gestational age of babies at time of birth in days | at time of birth |
| Birth Weight | Weight of baby at birth | at time of birth |
| Birth Length | Length of baby at birth | at time of birth |
| Measure | Description | Time Frame |
|---|---|---|
| Ponderal Index | Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics. | at time of birth |
| Gender of Babies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan E Carlson, PhD | University of Kansas Medical Center | Principal Investigator |
| John Colombo, PhD | University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| Truman Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23426033 | Result | Carlson SE, Colombo J, Gajewski BJ, Gustafson KM, Mundy D, Yeast J, Georgieff MK, Markley LA, Kerling EH, Shaddy DJ. DHA supplementation and pregnancy outcomes. Am J Clin Nutr. 2013 Apr;97(4):808-15. doi: 10.3945/ajcn.112.050021. Epub 2013 Feb 20. | |
| 25302772 | Result | Ozias MK, Kerling EH, Christifano DN, Scholtz SA, Colombo J, Carlson SE. Typical prenatal vitamin D supplement intake does not prevent decrease of plasma 25-hydroxyvitamin D at birth. J Am Coll Nutr. 2014;33(5):394-9. doi: 10.1080/07315724.2013.879843. Epub 2014 Oct 10. |
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Participants recruited from the Kansas City metro area. Enrollment occurred between January 2006 and November 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Capsule | Placebo capsule Placebo capsule: Placebo capsule |
| FG001 | DHA Supplement | DHA capsule DHA: 600 mg DHA |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled and Allocated Intervention |
| |||||||||||||
| Completed Follow-Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Capsule | Placebo capsule Placebo capsule: Placebo capsule |
| BG001 | DHA Supplement | DHA capsule DHA: 600 mg DHA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Total Fatty Acids by Weight | Measure of RBC-phospholipid-DHA at Birth | The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects. | Posted | Mean | Standard Deviation | percentage of fatty acid | at time of birth |
|
Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
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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 | Placebo Capsule - Mother | Placebo capsule Placebo capsule: Placebo capsule |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization or miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Carlson | University of Kansas Medical Center | 913-588-5359 | SCARLSON@kumc.edu |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Placebo capsule | Other | Placebo capsule |
|
| at time of birth |
| Cord RBC-phospholipid-DHA | Percentage of total fatty acids by weight in cord RBC | at time of birth |
| Head Circumference | Measure of circumference of baby's head in centimeters at time of birth. | at time of birth |
| Preterm Births | Percentage of births occurring at less than 37 weeks of gestation. | births before week 37 of gestation |
| Kansas City |
| Missouri |
| 64108 |
| United States |
| 25500337 | Result | Scholtz SA, Kerling EH, Shaddy DJ, Li S, Thodosoff JM, Colombo J, Carlson SE. Docosahexaenoic acid (DHA) supplementation in pregnancy differentially modulates arachidonic acid and DHA status across FADS genotypes in pregnancy. Prostaglandins Leukot Essent Fatty Acids. 2015 Mar;94:29-33. doi: 10.1016/j.plefa.2014.10.008. Epub 2014 Nov 7. |
| 31004139 | Derived | Colombo J, Shaddy DJ, Gustafson K, Gajewski BJ, Thodosoff JM, Kerling E, Carlson SE. The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation. Am J Clin Nutr. 2019 May 1;109(5):1380-1392. doi: 10.1093/ajcn/nqz018. |
| 30392575 | Derived | Carlson SE, Gajewski BJ, Alhayek S, Colombo J, Kerling EH, Gustafson KM. Dose-response relationship between docosahexaenoic acid (DHA) intake and lower rates of early preterm birth, low birth weight and very low birth weight. Prostaglandins Leukot Essent Fatty Acids. 2018 Nov;138:1-5. doi: 10.1016/j.plefa.2018.09.002. Epub 2018 Sep 20. |
| 30311214 | Derived | Lepping RJ, Honea RA, Martin LE, Liao K, Choi IY, Lee P, Papa VB, Brooks WM, Shaddy DJ, Carlson SE, Colombo J, Gustafson KM. Long-chain polyunsaturated fatty acid supplementation in the first year of life affects brain function, structure, and metabolism at age nine years. Dev Psychobiol. 2019 Jan;61(1):5-16. doi: 10.1002/dev.21780. Epub 2018 Oct 11. |
| 29381793 | Derived | Hidaka BH, Thodosoff JM, Kerling EH, Hull HR, Colombo J, Carlson SE. Intrauterine DHA exposure and child body composition at 5 y: exploratory analysis of a randomized controlled trial of prenatal DHA supplementation. Am J Clin Nutr. 2018 Jan 1;107(1):35-42. doi: 10.1093/ajcn/nqx007. |
| 27884184 | Derived | Hidaka BH, Kerling EH, Thodosoff JM, Sullivan DK, Colombo J, Carlson SE. Dietary patterns of early childhood and maternal socioeconomic status in a unique prospective sample from a randomized controlled trial of Prenatal DHA Supplementation. BMC Pediatr. 2016 Nov 25;16(1):191. doi: 10.1186/s12887-016-0729-0. |
| 27637340 | Derived | Yelland LN, Gajewski BJ, Colombo J, Gibson RA, Makrides M, Carlson SE. Predicting the effect of maternal docosahexaenoic acid (DHA) supplementation to reduce early preterm birth in Australia and the United States using results of within country randomized controlled trials. Prostaglandins Leukot Essent Fatty Acids. 2016 Sep;112:44-9. doi: 10.1016/j.plefa.2016.08.007. Epub 2016 Aug 17. |
| 27499448 | Derived | Shireman TI, Kerling EH, Gajewski BJ, Colombo J, Carlson SE. Docosahexaenoic acid supplementation (DHA) and the return on investment for pregnancy outcomes. Prostaglandins Leukot Essent Fatty Acids. 2016 Aug;111:8-10. doi: 10.1016/j.plefa.2016.05.008. Epub 2016 May 13. |
| 27362506 | Derived | Colombo J, Gustafson KM, Gajewski BJ, Shaddy DJ, Kerling EH, Thodosoff JM, Doty T, Brez CC, Carlson SE. Prenatal DHA supplementation and infant attention. Pediatr Res. 2016 Nov;80(5):656-662. doi: 10.1038/pr.2016.134. Epub 2016 Jun 30. |
| 23803884 | Derived | Colombo J, Carlson SE, Cheatham CL, Shaddy DJ, Kerling EH, Thodosoff JM, Gustafson KM, Brez C. Long-term effects of LCPUFA supplementation on childhood cognitive outcomes. Am J Clin Nutr. 2013 Aug;98(2):403-12. doi: 10.3945/ajcn.112.040766. Epub 2013 Jun 26. |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race of mother | Number | participants |
|
| Race/Ethnicity, Customized | Ethnicity of mother | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Gestation at Enrollment | Mean | Standard Deviation | days |
|
|
|
| Secondary | Ponderal Index | Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics. | Posted | Mean | Standard Deviation | units on a scale | at time of birth |
|
|
|
| Primary | Gestational Age | Gestational age of babies at time of birth in days | The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects. | Posted | Mean | Standard Deviation | days | at time of birth |
|
|
|
| Primary | Birth Weight | Weight of baby at birth | The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects. | Posted | Mean | Standard Deviation | grams | at time of birth |
|
|
|
| Primary | Birth Length | Length of baby at birth | The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects. | Posted | Mean | Standard Deviation | centimeters | at time of birth |
|
|
|
| Secondary | Gender of Babies | Posted | Number | percentage of babies | at time of birth |
|
|
|
| Secondary | Cord RBC-phospholipid-DHA | Percentage of total fatty acids by weight in cord RBC | Posted | Mean | Standard Deviation | percentage of cord RBC | at time of birth |
|
|
|
| Secondary | Head Circumference | Measure of circumference of baby's head in centimeters at time of birth. | Posted | Mean | Standard Deviation | centimeters | at time of birth |
|
|
|
| Secondary | Preterm Births | Percentage of births occurring at less than 37 weeks of gestation. | Posted | Number | percentage of births | births before week 37 of gestation |
|
|
|
| 18 |
| 147 |
| 0 |
| 147 |
| EG001 | Placebo Capsule - Infant | Infants born from Mothers in the Placebo capsule group | 31 | 147 | 0 | 147 |
| EG002 | DHA Capsule - Mother | DHA capsule DHA: 600 mg DHA | 18 | 154 | 0 | 154 |
| EG003 | DHA Capsule - Infant | Infants born from Mothers in the DHA capsule group | 26 | 154 | 0 | 154 |
| Hospitalization and death | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Congenital anomalies | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Postpartum hospitalization | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
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| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| Black Subjects (n=79,66) |
|
| Black Subjects (n=79,66) |
|
| Black Subjects (n=79,66) |
|