Kansas University DHA Outcome Study (KUDOS) Follow-Up
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 16 - 35 |
| Updated: | 2/9/2018 |
| Start Date: | July 2008 |
| End Date: | May 2016 |
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.
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.
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.
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.
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
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