Kansas University DHA Outcome Study (KUDOS) Follow-Up

Susan Carlson, PhD

Status and phase

Completed

Phase 3

Conditions

Pregnancy

Treatments

Drug: DHA

Drug: Placebo Capsule

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02487771

1R01HD047315 (U.S. NIH Grant/Contract)

11406

Details and patient eligibility

About

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.

Full 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.

Enrollment

190 patients

Sex

Female

Ages

16 to 35 years old

Volunteers

Accepts Healthy Volunteers

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