Trial · NCT00266825

DHA Supplementation and Pregnancy Outcome

NCT00266825, Phase 3, Completed, Susan Carlson, PhD; results first posted 2016-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. DHA Supplementation and Pregnancy Outcome. Trials, record NCT00266825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00266825

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: DHA Supplementation and Pregnancy Outcome
NCT number: NCT00266825
Status: Completed
Phases: Phase 3
Enrollment: 350 participants, actual
Lead sponsor: Susan Carlson, PhD
Conditions: Pregnancy
Interventions: DHA, Placebo capsule
First posted: 2005-12-19
Last updated: 2016-03-14
Results first posted: 2016-02-04

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Total Fatty Acids by Weight	at time of birth	Measure of RBC-phospholipid-DHA at Birth
Primary	Gestational Age	at time of birth	Gestational age of babies at time of birth in days
Primary	Birth Weight	at time of birth	Weight of baby at birth
Primary	Birth Length	at time of birth	Length of baby at birth
Secondary	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.
Secondary	Gender of Babies	at time of birth
Secondary	Cord RBC-phospholipid-DHA	at time of birth	Percentage of total fatty acids by weight in cord RBC
Secondary	Head Circumference	at time of birth	Measure of circumference of baby's head in centimeters at time of birth.
Secondary	Preterm Births	births before week 37 of gestation	Percentage of births occurring at less than 37 weeks of gestation.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Total Fatty Acids by Weight	at time of 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.	percentage of fatty acid	MEAN
SECONDARY	Ponderal Index	at time of birth		units on a scale	MEAN
PRIMARY	Gestational Age	at time of 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.	days	MEAN
PRIMARY	Birth Weight	at time of 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.	grams	MEAN
PRIMARY	Birth Length	at time of 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.	centimeters	MEAN
SECONDARY	Gender of Babies	at time of birth		percentage of babies	NUMBER
SECONDARY	Cord RBC-phospholipid-DHA	at time of birth		percentage of cord RBC	MEAN
SECONDARY	Head Circumference	at time of birth		centimeters	MEAN
SECONDARY	Preterm Births	births before week 37 of gestation		percentage of births	NUMBER

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Total Fatty Acids by Weight	Placebo Capsule	All Subjects	4.7	Standard Deviation 1.3	percentage of fatty acid
Percentage of Total Fatty Acids by Weight	DHA Supplement	All Subjects	7.3	Standard Deviation 2.2	percentage of fatty acid
Percentage of Total Fatty Acids by Weight	Placebo Capsule	Not Black Subjects (n=93, 112))	4.8	Standard Deviation 1.3	percentage of fatty acid
Percentage of Total Fatty Acids by Weight	DHA Supplement	Not Black Subjects (n=93, 112))	7.8	Standard Deviation 2.1	percentage of fatty acid
Percentage of Total Fatty Acids by Weight	Placebo Capsule	Black Subjects (n=79, 66)	4.7	Standard Deviation 1.3	percentage of fatty acid
Percentage of Total Fatty Acids by Weight	DHA Supplement	Black Subjects (n=79, 66)	6.2	Standard Deviation 2.0	percentage of fatty acid
Ponderal Index	Placebo Capsule		2.7	Standard Deviation 0.4	units on a scale
Ponderal Index	DHA Supplement		2.7	Standard Deviation 0.3	units on a scale
Gestational Age	Placebo Capsule	All Subjects	272.8	Standard Deviation 17.0	days
Gestational Age	DHA Supplement	All Subjects	275.7	Standard Deviation 11.2	days

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Enrolled and Allocated Intervention	STARTED	Placebo Capsule	172
Enrolled and Allocated Intervention	STARTED	DHA Supplement	178
Enrolled and Allocated Intervention	COMPLETED	Placebo Capsule	172
Enrolled and Allocated Intervention	COMPLETED	DHA Supplement	178
Enrolled and Allocated Intervention	NOT COMPLETED	Placebo Capsule	0
Enrolled and Allocated Intervention	NOT COMPLETED	DHA Supplement	0
Completed Follow-Up	STARTED	Placebo Capsule	172
Completed Follow-Up	STARTED	DHA Supplement	178
Completed Follow-Up	COMPLETED	Placebo Capsule	147
Completed Follow-Up	COMPLETED	DHA Supplement	154

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Hospitalization or miscarriage	Pregnancy, puerperium and perinatal conditions	Placebo Capsule - Mother	18	147	18
serious	Hospitalization or miscarriage	Pregnancy, puerperium and perinatal conditions	Placebo Capsule - Infant	0	0	0
serious	Hospitalization or miscarriage	Pregnancy, puerperium and perinatal conditions	DHA Capsule - Mother	18	154	18
serious	Hospitalization or miscarriage	Pregnancy, puerperium and perinatal conditions	DHA Capsule - Infant	0	0	0
serious	Hospitalization and death	Pregnancy, puerperium and perinatal conditions	Placebo Capsule - Mother	0	0	0
serious	Hospitalization and death	Pregnancy, puerperium and perinatal conditions	Placebo Capsule - Infant	31	147	31
serious	Hospitalization and death	Pregnancy, puerperium and perinatal conditions	DHA Capsule - Mother	0	0	0
serious	Hospitalization and death	Pregnancy, puerperium and perinatal conditions	DHA Capsule - Infant	26	154	26
serious	Congenital anomalies	Congenital, familial and genetic disorders	Placebo Capsule - Mother	0	0	0
serious	Congenital anomalies	Congenital, familial and genetic disorders	Placebo Capsule - Infant	2	147	2

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Capsule - Mother
Total, all-cause mortality	Placebo Capsule - Infant
Total, all-cause mortality	DHA Capsule - Mother
Total, all-cause mortality	DHA Capsule - Infant
Total, other adverse events	Placebo Capsule - Mother	0	147
Total, other adverse events	Placebo Capsule - Infant	0	147
Total, other adverse events	DHA Capsule - Mother	0	154
Total, other adverse events	DHA Capsule - Infant	0	154
Total, serious adverse events	Placebo Capsule - Mother	18	147
Total, serious adverse events	Placebo Capsule - Infant	31	147

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers12

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23426033	RESULT	PubMed
23803884	DERIVED	PubMed
25302772	RESULT	PubMed
25500337	RESULT	PubMed
27362506	DERIVED	PubMed
27499448	DERIVED	PubMed
27637340	DERIVED	PubMed
27884184	DERIVED	PubMed
29381793	DERIVED	PubMed
30311214	DERIVED	PubMed

1 to 10 of 12

See all 12 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HD047315	DHA Supplementation and Pregnancy Outcome	CARLSON, SUSAN E; COLOMBO, JOHN A.	UNIVERSITY OF KANSAS MEDICAL CENTER	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2006 to 2016

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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