DHA Supplementation and Pregnancy Outcome

Conditions

Pregnancy

Brief summary

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.

Detailed description

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.

Colombo J, Shaddy DJ, Gustafson K, Gajewski BJ, Thodosoff JM, Kerling E, Carlson SE.

2019-05-0147 citations

10.1093/ajcn/nqz018

Effect of Prenatal Docosahexaenoic Acid Supplementation on Blood Pressure in Children With Overweight Condition or Obesity

Elizabeth H. Kerling, Jamie M. Hilton, Jocelynn M. Thodosoff, Jo Wick, John Colombo et al. (6 authors)

JAMA Network Open2019-02-2211 citations

10.1001/jamanetworkopen.2019.0088

Intrauterine DHA exposure and child body composition at 5 y: exploratory analysis of a randomized controlled trial of prenatal DHA supplementation.

Hidaka BH, Thodosoff JM, Kerling EH, Hull HR, Colombo J, Carlson SE.

2018-01-0115 citations

10.1093/ajcn/nqx007

Dietary patterns of early childhood and maternal socioeconomic status in a unique prospective sample from a randomized controlled trial of Prenatal DHA Supplementation

Brandon H. Hidaka, Elizabeth H. Kerling, Jocelynn M. Thodosoff, Debra K. Sullivan, John Colombo et al. (6 authors)

BMC Pediatrics2016-11-2513 citations

10.1186/s12887-016-0729-0

Does n-3 LCPUFA supplementation during pregnancy increase the IQ of children at school age? Follow-up of a randomised controlled trial

Jacqueline F. Gould, Karli Treyvaud, Lisa N Yelland, Peter J. Anderson, Lisa G. Smithers et al. (8 authors)

BMJ Open2016-05-0121 citations

10.1136/bmjopen-2016-011465

Long-term effects of LCPUFA supplementation on childhood cognitive outcomes.

Colombo J, Carlson SE, Cheatham CL, Shaddy DJ, Kerling EH, Thodosoff JM, Gustafson KM, Brez C.

2013-06-26128 citations

10.3945/ajcn.112.040766

DHA supplementation and pregnancy outcomes.

Carlson SE, Colombo J, Gajewski BJ, Gustafson KM, Mundy D, Yeast J, Georgieff MK, Markley LA, Kerling EH, Shaddy DJ.

2013-02-20219 citations

10.3945/ajcn.112.050021

Interventions

DRUGDHA

600 mg DHA

OTHERPlacebo capsule

Placebo capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 36 Years

Healthy volunteers

Yes

Inclusion criteria

* Pregnant 8-20 wks at enrollment * single fetus * BMI \<40

Exclusion criteria

* diabetes (Type I, ii, GDM) * hypertension (primary, PIH, preeclampsia/eclampsia)

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Total Fatty Acids by Weight	at time of birth	Measure of RBC-phospholipid-DHA at Birth
Gestational Age	at time of birth	Gestational age of babies at time of birth in days
Birth Weight	at time of birth	Weight of baby at birth
Birth Length	at time of birth	Length of baby at birth

Secondary

Measure	Time frame	Description
Ponderal Index	at time of birth	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.
Preterm Births	births before week 37 of gestation	Percentage of births occurring at less than 37 weeks of gestation.
Gender of Babies	at time of birth	—
Cord RBC-phospholipid-DHA	at time of birth	Percentage of total fatty acids by weight in cord RBC
Head Circumference	at time of birth	Measure of circumference of baby's head in centimeters at time of birth.

Countries

United States

Participant flow

Recruitment details

Participants recruited from the Kansas City metro area. Enrollment occurred between January 2006 and November 2009.

Participants by arm

Arm	Count
Placebo Capsule Placebo capsule Placebo capsule: Placebo capsule	172
DHA Supplement DHA capsule DHA: 600 mg DHA	178
Total	350

Withdrawals & dropouts

Period	Reason	FG000	FG001
Completed Follow-Up	Lost to Follow-up	14	19
Completed Follow-Up	Withdrawal by Subject	11	5

Baseline characteristics

Characteristic	Placebo Capsule	DHA Supplement	Total
Age, Continuous	24.8 years STANDARD_DEVIATION 4.7	25.3 years STANDARD_DEVIATION 4.9	25.0 years STANDARD_DEVIATION 4.8
Gestation at Enrollment	99.6 days STANDARD_DEVIATION 26.1	102.9 days STANDARD_DEVIATION 25.3	101.3 days STANDARD_DEVIATION 25.7
Race/Ethnicity, Customized Black	79 participants	66 participants	145 participants
Race/Ethnicity, Customized Hispanic	14 participants	14 participants	28 participants
Race/Ethnicity, Customized Not Black	93 participants	112 participants	205 participants
Race/Ethnicity, Customized Not Hispanic	158 participants	164 participants	322 participants
Region of Enrollment United States	172 participants	178 participants	350 participants
Sex: Female, Male Female	172 Participants	178 Participants	350 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 147	0 / 147	0 / 154	0 / 154
serious Total, serious adverse events	18 / 147	31 / 147	18 / 154	26 / 154

Outcome results

Primary

Birth Length

Length of baby at birth

Time frame: at time of birth

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo Capsule	Birth Length	All Subjects	49.0 centimeters	Standard Deviation 3.4
Placebo Capsule	Birth Length	Not Black Subjects (n=93,112)	49.2 centimeters	Standard Deviation 2.9
Placebo Capsule	Birth Length	Black Subjects (n=79,66)	48.6 centimeters	Standard Deviation 4
DHA Supplement	Birth Length	All Subjects	49.7 centimeters	Standard Deviation 2.7
DHA Supplement	Birth Length	Not Black Subjects (n=93,112)	50.0 centimeters	Standard Deviation 2.6
DHA Supplement	Birth Length	Black Subjects (n=79,66)	49.0 centimeters	Standard Deviation 2.7

Primary

Birth Weight

Weight of baby at birth

Time frame: at time of birth

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo Capsule	Birth Weight	All Subjects	3187 grams	Standard Deviation 602
Placebo Capsule	Birth Weight	Not Black Subjects (n=93,112)	3282 grams	Standard Deviation 529
Placebo Capsule	Birth Weight	Black Subjects (n=79,66)	3060 grams	Standard Deviation 671
DHA Supplement	Birth Weight	All Subjects	3359 grams	Standard Deviation 524
DHA Supplement	Birth Weight	Not Black Subjects (n=93,112)	3489 grams	Standard Deviation 456
DHA Supplement	Birth Weight	Black Subjects (n=79,66)	3110 grams	Standard Deviation 559

Primary

Gestational Age

Gestational age of babies at time of birth in days

Time frame: at time of birth

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo Capsule	Gestational Age	All Subjects	272.8 days	Standard Deviation 17
Placebo Capsule	Gestational Age	Not Black Subjects (n=93,112)	273.8 days	Standard Deviation 14
Placebo Capsule	Gestational Age	Black Subjects (n=79,66)	271.4 days	Standard Deviation 20.3
DHA Supplement	Gestational Age	All Subjects	275.7 days	Standard Deviation 11.2
DHA Supplement	Gestational Age	Not Black Subjects (n=93,112)	275.9 days	Standard Deviation 9.9
DHA Supplement	Gestational Age	Black Subjects (n=79,66)	275.2 days	Standard Deviation 13.3

Primary

Percentage of Total Fatty Acids by Weight

Measure of RBC-phospholipid-DHA at Birth

Time frame: at time of birth

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo Capsule	Percentage of Total Fatty Acids by Weight	All Subjects	4.7 percentage of fatty acid	Standard Deviation 1.3
Placebo Capsule	Percentage of Total Fatty Acids by Weight	Not Black Subjects (n=93, 112))	4.8 percentage of fatty acid	Standard Deviation 1.3
Placebo Capsule	Percentage of Total Fatty Acids by Weight	Black Subjects (n=79, 66)	4.7 percentage of fatty acid	Standard Deviation 1.3
DHA Supplement	Percentage of Total Fatty Acids by Weight	Black Subjects (n=79, 66)	6.2 percentage of fatty acid	Standard Deviation 2
DHA Supplement	Percentage of Total Fatty Acids by Weight	All Subjects	7.3 percentage of fatty acid	Standard Deviation 2.2
DHA Supplement	Percentage of Total Fatty Acids by Weight	Not Black Subjects (n=93, 112))	7.8 percentage of fatty acid	Standard Deviation 2.1

Secondary

Cord RBC-phospholipid-DHA

Percentage of total fatty acids by weight in cord RBC

Time frame: at time of birth

Arm	Measure	Value (MEAN)	Dispersion
Placebo Capsule	Cord RBC-phospholipid-DHA	5.9 percentage of cord RBC	Standard Deviation 1.4
DHA Supplement	Cord RBC-phospholipid-DHA	7.3 percentage of cord RBC	Standard Deviation 1.8

Secondary

Gender of Babies

Time frame: at time of birth

Arm	Measure	Group	Value (NUMBER)
Placebo Capsule	Gender of Babies	Male	54 percentage of babies
Placebo Capsule	Gender of Babies	Female	46 percentage of babies
DHA Supplement	Gender of Babies	Male	49 percentage of babies
DHA Supplement	Gender of Babies	Female	51 percentage of babies

Secondary

Head Circumference

Measure of circumference of baby's head in centimeters at time of birth.

Time frame: at time of birth

Arm	Measure	Value (MEAN)	Dispersion
Placebo Capsule	Head Circumference	33.7 centimeters	Standard Deviation 2
DHA Supplement	Head Circumference	34.2 centimeters	Standard Deviation 1.7

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.

Time frame: at time of birth

Arm	Measure	Value (MEAN)	Dispersion
Placebo Capsule	Ponderal Index	2.7 units on a scale	Standard Deviation 0.4
DHA Supplement	Ponderal Index	2.7 units on a scale	Standard Deviation 0.3

Secondary

Preterm Births

Percentage of births occurring at less than 37 weeks of gestation.

Time frame: births before week 37 of gestation

Arm	Measure	Value (NUMBER)
Placebo Capsule	Preterm Births	8.8 percentage of births
DHA Supplement	Preterm Births	7.8 percentage of births

DHA Supplementation and Pregnancy Outcome

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Birth Length

Birth Weight

Gestational Age

Percentage of Total Fatty Acids by Weight

Cord RBC-phospholipid-DHA

Gender of Babies

Head Circumference

Ponderal Index

Preterm Births