Trial · NCT02487771

Kansas University DHA Outcome Study (KUDOS) Follow-Up

NCT02487771, Phase 3, Completed, Susan Carlson, PhD; results first posted 2017-09-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Kansas University DHA Outcome Study (KUDOS) Follow-Up. Trials, record NCT02487771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02487771

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Trial

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

Title: Kansas University DHA Outcome Study (KUDOS) Follow-Up
NCT number: NCT02487771
Status: Completed
Phases: Phase 3
Enrollment: 190 participants, actual
Lead sponsor: Susan Carlson, PhD
Conditions: Pregnancy
Interventions: DHA, Placebo Capsule
First posted: 2015-07-01
Last updated: 2018-02-07
Results first posted: 2017-09-25

Source ClinicalTrials.gov

Registered outcomes72

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

List	Outcome	Time frame	Description
Primary	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	36 Months	The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Primary	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	48 Months	The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Primary	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	72 Months	The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Primary	Cognitive Function Score - Peabody Picture Vocabulary Test	60 Months	The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15.
Primary	Cognitive Function Score - Test of Preschool Early Literacy	42 Months	The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15.
Primary	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ	36 Months	The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Primary	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ	48 Months	The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Primary	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ	72 Months	The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Secondary	Adaptive Regulation Assessment	36 Months	The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
Secondary	Adaptive Regulation Assessment	48 Months	The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.

1 to 10 of 72Source ClinicalTrials.gov

See all 72 registered outcomes

Outcomes73

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	36 Months	Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.	units on a scale	MEAN
PRIMARY	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	48 Months	Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.	units on a scale	MEAN
PRIMARY	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	72 Months	Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.	units on a scale	MEAN
PRIMARY	Cognitive Function Score - Peabody Picture Vocabulary Test	60 Months	Missing data due to attrition, missed appointments, refusals, or questionable test.	units on a scale	MEAN
PRIMARY	Cognitive Function Score - Test of Preschool Early Literacy	42 Months	Missing data due to attrition, missed appointments, refusals, or questionable test.	units on a scale	MEAN
PRIMARY	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ	36 Months	Missing data due to attrition, missed appointments, refusals, or questionable test	units on a scale	MEAN
PRIMARY	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ	48 Months	Missing data due to attrition, missed appointments, refusals, or questionable test	units on a scale	MEAN
PRIMARY	Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ	72 Months	Missing data due to attrition, missed appointments, refusals, or questionable test	units on a scale	MEAN
SECONDARY	Adaptive Regulation Assessment	36 Months	Missing data due to attrition, missed appointments, refusals.	T-scores	MEAN
SECONDARY	Adaptive Regulation Assessment	48 Months	Missing data due to attrition, missed appointments, refusals.	T-scores	MEAN

1 to 10 of 73Source ClinicalTrials.gov

See all 73 outcomes

Results by group172

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

Outcome	Group	Value	Spread	Units
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	Placebo Capsule	98.78	Standard Deviation 15.43	units on a scale
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	DHA Capsule	98.75	Standard Deviation 15.75	units on a scale
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	Placebo Capsule	97.52	Standard Deviation 15.32	units on a scale
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	DHA Capsule	99.72	Standard Deviation 16.10	units on a scale
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	Placebo Capsule	100.67	Standard Deviation 14.70	units on a scale
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ	DHA Capsule	102.21	Standard Deviation 14.02	units on a scale
Cognitive Function Score - Peabody Picture Vocabulary Test	Placebo Capsule	101.07	Standard Deviation 14.92	units on a scale
Cognitive Function Score - Peabody Picture Vocabulary Test	DHA Capsule	102.35	Standard Deviation 15.33	units on a scale
Cognitive Function Score - Test of Preschool Early Literacy	Placebo Capsule	92.99	Standard Deviation 18.76	units on a scale
Cognitive Function Score - Test of Preschool Early Literacy	DHA Capsule	95.08	Standard Deviation 18.80	units on a scale

1 to 10 of 172Source ClinicalTrials.gov

See all 172 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Capsule	91
Overall Study	STARTED	DHA Capsule	99
Overall Study	COMPLETED	Placebo Capsule	81
Overall Study	COMPLETED	DHA Capsule	85
Overall Study	NOT COMPLETED	Placebo Capsule	10
Overall Study	NOT COMPLETED	DHA Capsule	14

Source ClinicalTrials.gov

Adverse events0

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

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Capsule
Total, all-cause mortality	DHA Capsule
Total, other adverse events	Placebo Capsule	0	0
Total, other adverse events	DHA Capsule	0	0
Total, serious adverse events	Placebo Capsule	0	0
Total, serious adverse events	DHA Capsule	0	0

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30794304	DERIVED	PubMed
31004139	DERIVED	PubMed

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.

Tests1

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

Test	Named as
Vocabulary Test	Primary outcome

Source ConductCognition

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.

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