Kansas University DHA Outcome Study (KUDOS) Follow-Up

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Susan Carlson, PhD
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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