PregnancyPhase 3NCT00266825

DHA Supplementation and Pregnancy Outcome

A Phase 3 study testing DHA in people with Pregnancy, run by Susan Carlson, PhD at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 16 to 36 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy
What is being tested?: DHA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 350 participants
Where: 2 sitesUnited States
Study dates: Jan 2006to Oct 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 36 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Kansas Medical Center
Kansas City, Kansas, 66160
Truman Medical Center
Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: Kansas University DHA Outcome Study (KUDOS)

Read the 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.

Conditions: Pregnancy
Being tested: DHA, Placebo capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DHADrug
Also called docosahexaenoic acid
600 mg DHA
Placebo capsuleOther
Placebo capsule

Study groups in NCT00266825
Study group	Role	What they receive
DHA capsules	Experimental	DHA capsules Receives: Drug: DHA
Placebo capsules	Placebo comparator	Placebo capsule Receives: Other: Placebo capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Oct 2011

First posted19 Dec 2005 (estimated)
Study startJan 2006
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for PregnancyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00266825
Sponsor's protocol ID: 10186
Other IDs: R01HD047315
Status last verified: Feb 2016
First submitted: 15 Dec 2005
Last updated: 14 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

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.
PubMed 23426033
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.
PubMed 25302772
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.
PubMed 25500337
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.
PubMed 31004139
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.
PubMed 30392575
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.
PubMed 30311214
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.
PubMed 29381793
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.
PubMed 27884184
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.
PubMed 27637340
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.
PubMed 27499448
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.
PubMed 27362506
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.
PubMed 23803884

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pregnancy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Kansas University DHA Outcome Study (KUDOS)
ClinicalTrials.gov ID: NCT00266825
Acronym / sponsor ID: 10186
Conditions: Pregnancy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: Susan Carlson, PhDUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Jan 2006
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 19 Dec 2005 (estimated)
Results: Posted 4 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DHA capsules	Experimental	Drug: DHADHA capsules
Placebo capsules	Placebo comparator	Other: Placebo capsulePlacebo capsule

Who may qualify

Ages: 16 to 36 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DHAAlso: docosahexaenoic acid600 mg DHA	Drug	DHA capsules
Placebo capsulePlacebo capsule	Other	Placebo capsules

Primary outcome

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

5 secondary outcomes

Ponderal Index
Time frame: at time of birth
Gender of Babies
Time frame: at time of birth
Cord RBC-phospholipid-DHA
Time frame: at time of birth
Head Circumference
Time frame: at time of birth
Preterm Births
Time frame: births before week 37 of gestation

Results and safety

Results posted to the registry on 4 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Capsule	172	172
DHA Supplement	178	178

Primary outcome: Percentage of Total Fatty Acids by Weight

Time frame: at time of birth. Mean (Standard Deviation). Unit: percentage of fatty acid

Measure	Placebo Capsule n = 147	DHA Supplement n = 154
All Subjects	4.7 (1.3)	7.3 (2.2)
Not Black Subjects (n=93, 112))	4.8 (1.3)	7.8 (2.1)
Black Subjects (n=79, 66)	4.7 (1.3)	6.2 (2.0)

Population analysed: 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.

Primary outcome: Gestational Age

Time frame: at time of birth. Mean (Standard Deviation). Unit: days

Measure	Placebo Capsule n = 147	DHA Supplement n = 154
All Subjects	272.8 (17.0)	275.7 (11.2)
Not Black Subjects (n=93,112)	273.8 (14.0)	275.9 (9.9)
Black Subjects (n=79,66)	271.4 (20.3)	275.2 (13.3)

Primary outcome: Birth Weight

Time frame: at time of birth. Mean (Standard Deviation). Unit: grams

Measure	Placebo Capsule n = 147	DHA Supplement n = 154
All Subjects	3187 (602)	3359 (524)
Not Black Subjects (n=93,112)	3282 (529)	3489 (456)
Black Subjects (n=79,66)	3060 (671)	3110 (559)

Primary outcome: Birth Length

Time frame: at time of birth. Mean (Standard Deviation). Unit: centimeters

Measure	Placebo Capsule n = 147	DHA Supplement n = 154
All Subjects	49.0 (3.4)	49.7 (2.7)
Not Black Subjects (n=93,112)	49.2 (2.9)	50.0 (2.6)
Black Subjects (n=79,66)	48.6 (4.0)	49.0 (2.7)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Capsule - Mother	18 of 147 (12.2%)	0 of 147 (0%)	Not reported
Placebo Capsule - Infant	31 of 147 (21.1%)	0 of 147 (0%)	Not reported
DHA Capsule - Mother	18 of 154 (11.7%)	0 of 154 (0%)	Not reported
DHA Capsule - Infant	26 of 154 (16.9%)	0 of 154 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23426033Carlson 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.
Results publication: PubMed 25302772Ozias 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.
Results publication: PubMed 25500337Scholtz 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.
Derived from this study: PubMed 31004139Colombo 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.
Derived from this study: PubMed 30392575Carlson 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.
Derived from this study: PubMed 30311214Lepping 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.
Derived from this study: PubMed 29381793Hidaka 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.
Derived from this study: PubMed 27884184Hidaka 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.
Derived from this study: PubMed 27637340Yelland 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.
Derived from this study: PubMed 27499448Shireman 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.
Derived from this study: PubMed 27362506Colombo 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.
Derived from this study: PubMed 23803884Colombo 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan E Carlson, PhD principal investigator

University of Kansas Medical Center

John Colombo, PhD principal investigator

University of Kansas

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DHA in people with Pregnancy, run by Susan Carlson, PhD at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Total Fatty Acids by Weight (time frame: at time of birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00266825, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.