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Phase 3 Completed N=190 Randomized Double-blind Treatment

Kansas University DHA Outcome Study (KUDOS) Follow-Up

Source: ClinicalTrials.gov NCT02487771 ↗
Enrolled (actual)
190
Serious AEs
Results posted
Sep 2017
Primary outcomePrimary: Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ — 98.78; 98.75 units on a scale
◆ Published Evidence
Established
61citations · ~9 / year
The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation.
The American journal of clinical nutrition · 2019 · Open access · Likely link

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.

Linked Publications (2)

  • The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation.
    The American journal of clinical nutrition · 2019 · 61 citations · Open access · Likely link
  • 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 network open · 2019 · 11 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
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
SECONDARY
Adaptive Regulation Assessment
50.10; 49.37; 46.80; 45.96; 48.99; 49.17

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02487771) and the linked publication. 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. Informational only — not medical advice.

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