Clinical trial NCT02487771: Kansas University DHA Outcome Study (KUDOS) Follow-Up
Official title: Kansas University DHA Outcome Study (KUDOS) Follow-Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Keywords: DHA
childhood development
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-07-01
Enrollment: 190
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Numerous trials show benefits of postnatal DHA supplementation for visual acuity. There are also numerous observational(not intervention)studies that link higher maternal DHA status during pregnancy to higher cognitive function. Intervention studies that increase DHA exposure during fetal life and that measure cognitive development of infants are lacking; and no study to date has systematically followed children whose mothers were randomly assigned to DHA supplementation to school age with regular 6 month assessments of age-appropriate assessments of cognitive development. The absence of such studies is a serious limitation because there is evidence that differences in cognitive function due to such interventions do not become robust until around age 4 years. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
timeFrame: 36 Months
measure: Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
timeFrame: 48 Months
measure: Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
timeFrame: 72 Months
measure: Cognitive Function Score - Peabody Picture Vocabulary Test
timeFrame: 60 Months
measure: Cognitive Function Score - Test of Preschool Early Literacy
timeFrame: 42 Months
measure: Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
timeFrame: 36 Months
measure: Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
timeFrame: 48 Months
measure: Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
timeFrame: 72 Months
Secondary outcomes:
measure: Adaptive Regulation Assessment
timeFrame: 36 Months
measure: Adaptive Regulation Assessment
timeFrame: 48 Months
measure: Adaptive Regulation Assessment
timeFrame: 60 Months
measure: Adaptive Regulation Assessment
timeFrame: 72 Months
Other outcomes:
measure: Anthropometrics: Weight-for-age
timeFrame: 2 years
measure: Anthropometrics: Weight-for-age
timeFrame: 2.5 years
measure: Anthropometrics: Weight-for-age
timeFrame: 3 years
measure: Anthropometrics: Height-for-Age
timeFrame: 2 years
measure: Anthropometrics: Weight-for-age
timeFrame: 3.5 years
measure: Anthropometrics: Weight-for-age
timeFrame: 4 years
measure: Anthropometrics: Weight-for-age
timeFrame: 4.5 years
measure: Anthropometrics: Weight-for-age
timeFrame: 5 years
measure: Anthropometrics: Weight-for-age
timeFrame: 5.5 years
measure: Anthropometrics: Weight-for-age
timeFrame: 6 years
measure: Anthropometrics: Height-for-Age
timeFrame: 2.5 years
measure: Anthropometrics: Height-for-Age
timeFrame: 3 years
measure: Anthropometrics: Height-for-Age
timeFrame: 3.5 years
measure: Anthropometrics: Height-for-Age
timeFrame: 4 years
measure: Anthropometrics: Height-for-Age
timeFrame: 4.5 years
measure: Anthropometrics: Height-for-Age
timeFrame: 5 years
measure: Anthropometrics: Height-for-Age
timeFrame: 5.5 years
measure: Anthropometrics: Height-for-Age
timeFrame: 6 years
measure: Anthropometrics: Body Mass Index-for-age
timeFrame: 2 years
measure: Anthropometrics: Body Mass Index-for-age
timeFrame: 2.5 years
measure: Anthropometrics: Body Mass Index-for-age
timeFrame: 3 years
measure: Anthropometrics: Body Mass Index-for-age
timeFrame: 3.5 years
measure: Anthropometrics: Body Mass Index-for-age
timeFrame: 4 years
measure: Anthropometrics: Body Mass Index-for-age
timeFrame: 4.5 years
measure: Anthropometrics: Body Mass Index-for-age
timeFrame: 5 years
measure: Anthropometrics: Body Mass Index-for-age
timeFrame: 5.5 years
measure: Anthropometrics: Body Mass Index-for-age
timeFrame: 6 years
measure: Anthropometrics: Head Circumference-for-age
timeFrame: 2 years
measure: Anthropometrics: Head Circumference-for-age
timeFrame: 2.5 years
measure: Anthropometrics: Head Circumference-for-age
timeFrame: 3 years
measure: Anthropometrics: Head Circumference-for-age
timeFrame: 3.5 years
measure: Anthropometrics: Head Circumference-for-age
timeFrame: 4 years
measure: Anthropometrics: Head Circumference-for-age
timeFrame: 4.5 years
measure: Anthropometrics: Head Circumference-for-age
timeFrame: 5 years
measure: Anthropometrics: Head Circumference-for-age
timeFrame: 5.5 years
measure: Anthropometrics: Head Circumference-for-age
timeFrame: 6 years
measure: Dietary Intake
timeFrame: 2 years
measure: Dietary Intake
timeFrame: 2.5 years
measure: Dietary Intake
timeFrame: 3 years
measure: Dietary Intake
timeFrame: 3.5 years
measure: Dietary Intake
timeFrame: 4 years
measure: Dietary Intake
timeFrame: 4.5 years
measure: Dietary Intake
timeFrame: 5 years
measure: Dietary Intake
timeFrame: 5.5 years
measure: Dietary Intake
timeFrame: 6 years
measure: Systolic Blood Pressure
timeFrame: 4 years
measure: Systolic Blood Pressure
timeFrame: 4.5 years
measure: Systolic Blood Pressure
timeFrame: 5 years
measure: Systolic Blood Pressure
timeFrame: 5.5 years
measure: Systolic Blood Pressure
timeFrame: 6 years
measure: Diastolic Blood Pressure
timeFrame: 4 years
measure: Diastolic Blood Pressure
timeFrame: 4.5 years
measure: Diastolic Blood Pressure
timeFrame: 5 years
measure: Diastolic Blood Pressure
timeFrame: 5.5 years
measure: Diastolic Blood Pressure
timeFrame: 6 years
measure: Heart Rate
timeFrame: 4 years
measure: Heart Rate
timeFrame: 4.5 years
measure: Heart Rate
timeFrame: 5 years
measure: Heart Rate
timeFrame: 5.5 years
measure: Heart Rate
timeFrame: 6 years
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Susan E Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.