NCT00266825

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P25-P50 for phase_3 pregnancy

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_3 pregnancy

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

December 15, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2005

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

February 4, 2016

Completed
Last Updated

March 14, 2016

Status Verified

February 1, 2016

Enrollment Period

5.8 years

First QC Date

December 15, 2005

Results QC Date

June 30, 2015

Last Update Submit

February 11, 2016

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (5)

  • Ponderal Index

    at time of birth

  • Gender of Babies

    at time of birth

  • Cord RBC-phospholipid-DHA

    at time of birth

  • Head Circumference

    at time of birth

  • Preterm Births

    births before week 37 of gestation

Study Arms (2)

DHA capsules

EXPERIMENTAL

DHA capsules

Drug: DHA

Placebo capsules

PLACEBO COMPARATOR

Placebo capsule

Other: Placebo capsule

Interventions

DHADRUG

600 mg DHA

Also known as: docosahexaenoic acid
DHA capsules
Placebo capsuleOTHER

Placebo capsule

Placebo capsules

Eligibility Criteria

Age16 Years - 36 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Related Publications (12)

  • 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.

    PMID: 23426033RESULT

  • 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.

    PMID: 25302772RESULT

  • 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.

    PMID: 25500337RESULT

  • 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

  • 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.

    PMID: 30392575DERIVED

  • 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.

    PMID: 30311214DERIVED

  • 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.

    PMID: 29381793DERIVED

  • 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.

    PMID: 27884184DERIVED

  • 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.

    PMID: 27637340DERIVED

  • 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.

    PMID: 27499448DERIVED

  • 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.

    PMID: 27362506DERIVED

  • 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.

    PMID: 23803884DERIVED

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Susan Carlson
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

  • John Colombo, PhD

    University of Kansas

    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

December 15, 2005

First Posted

December 19, 2005

Study Start

January 1, 2006

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

March 14, 2016

Results First Posted

February 4, 2016

Record last verified: 2016-02

Locations

US(2)