NCT02487771

Brief Summary

This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to follow-up with participants on the original study to determine if the effects of increasing DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P25-P50 for phase_3 pregnancy

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_3 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
3 years until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 25, 2017

Completed
Last Updated

February 7, 2018

Status Verified

January 1, 2018

Enrollment Period

7.8 years

First QC Date

June 18, 2012

Results QC Date

July 20, 2017

Last Update Submit

January 29, 2018

Conditions

Pregnancy

Keywords

DHAchildhood development

Outcome Measures

Primary Outcomes (8)

  • Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ

    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.

    36 Months

  • Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ

    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.

    48 Months

  • Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ

    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.

    72 Months

  • Cognitive Function Score - Peabody Picture Vocabulary Test

    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.

    60 Months

  • Cognitive Function Score - Test of Preschool Early Literacy

    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.

    42 Months

  • Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ

    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.

    36 Months

  • Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ

    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.

    48 Months

  • Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ

    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.

    72 Months

Secondary Outcomes (4)

  • Adaptive Regulation Assessment

    36 Months

  • Adaptive Regulation Assessment

    48 Months

  • Adaptive Regulation Assessment

    60 Months

  • Adaptive Regulation Assessment

    72 Months

Other Outcomes (60)

  • Anthropometrics: Weight-for-age

    2 years

  • Anthropometrics: Weight-for-age

    2.5 years

  • Anthropometrics: Weight-for-age

    3 years

  • +57 more other outcomes

Study Arms (2)

Placebo Capsule

PLACEBO COMPARATOR
Drug: Placebo Capsule

DHA Capsule

EXPERIMENTAL
Drug: DHA

Interventions

DHADRUG

600 mg DHA capsule

Also known as: docosahexaenoic acid
DHA Capsule
Placebo CapsuleDRUG

600 mg of Soybean Oil and Corn Oil, which does not contain any DHA

Placebo Capsule

Eligibility Criteria

Age16 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant females 16.0-35.0 years of age (inclusive) at 8-20 weeks gestation at enrollment (date/ultrasound)
  • Agree to consume study capsules from enrollment until delivery
  • Agree to return to the study center for delivery
  • BMI \< 40
  • No serious illnesses (e.g., cancer, diabetes, lupus, hepatitis, sexually transmitted diseases, not HIV positive)
  • Available by telephone

You may not qualify if:

  • Less than 16 or greater than 35 years of age
  • BMI \< 40
  • Serious illness such as cancer, lupus, hepatitis, sexually transmitted disease or HIV positive
  • Expecting multiple infants
  • Diabetes or gestational diabetes at baseline
  • Elevated blood pressure due to any cause
  • Not planning to return to the study center for delivery
  • Gestational age at baseline \< 8 weeks or \>20 weeks
  • Unable or unwilling to agree to consume capsules until delivery
  • Unable to provide informed consent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

  • 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.

    PMID: 31004139DERIVED

  • Kerling EH, Hilton JM, Thodosoff JM, Wick J, Colombo J, Carlson SE. Effect of Prenatal Docosahexaenoic Acid Supplementation on Blood Pressure in Children With Overweight Condition or Obesity: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190088. doi: 10.1001/jamanetworkopen.2019.0088.

    PMID: 30794304DERIVED

Related Links

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Results Point of Contact

Title
Susan Carlson, PhD
Organization
University of Kansas Medical Center
SCARLSON@kumc.edu
(913) 588-5359

Study Officials

  • Susan E Carlson, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2012

First Posted

July 1, 2015

Study Start

July 1, 2008

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

February 7, 2018

Results First Posted

September 25, 2017

Record last verified: 2018-01

Locations

US(1)