Phase 3
N=190
Kansas University DHA Outcome Study (KUDOS) Follow-Up
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02487771 ↗Enrolled (actual)
190
Serious AEs
—
Results posted
Sep 2017
Primary outcome: Primary: Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ — 98.78; 98.75 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DHA (Drug); Placebo Capsule (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Susan Carlson, PhD
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ |
100.67; 102.21 | — |
| PRIMARY Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ |
100.67; 102.21 | — |
| PRIMARY Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ |
100.67; 102.21 | — |
| PRIMARY Cognitive Function Score - Peabody Picture Vocabulary Test |
101.07; 102.35 | — |
| PRIMARY Cognitive Function Score - Test of Preschool Early Literacy |
92.99; 95.08 | — |
| PRIMARY Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ |
101.53; 102.44 | — |
| PRIMARY Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ |
101.53; 102.44 | — |
| PRIMARY Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ |
101.53; 102.44 | — |
| SECONDARY Adaptive Regulation Assessment |
50.10; 49.37; 46.80; 45.96; 48.99; 49.17 | — |
| SECONDARY Adaptive Regulation Assessment |
50.10; 49.37; 46.80; 45.96; 48.99; 49.17 | — |
| SECONDARY Adaptive Regulation Assessment |
50.10; 49.37; 46.80; 45.96; 48.99; 49.17 | — |
| SECONDARY Adaptive Regulation Assessment |
50.10; 49.37; 46.80; 45.96; 48.99; 49.17 | — |
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.
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 20 weeks
- Unable or unwilling to agree to consume capsules until delivery
- Unable to provide informed consent in English
Data sourced from ClinicalTrials.gov (NCT02487771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.