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OpenTrials
Completed

NCT Number: NCT03310983

Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation

The purpose of this study is to learn if participants in the ADORE study (NCT02626299), who took a DHA supplement during pregnancy, see favorable body fat in their infants from birth to 24 months, and if excessive or appropriate weight gain during pregnancy impacts this result.

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Key information

Conditions

Pregnancy; Nutritional Diseases Body Weight Body Weight Changes Gestational Weight Gain Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Participants for this study are invited from the parent study, ADORE. Eligibility listed reflects criteria for the ADORE study.

Inclusion criteria

  • Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
  • Available by telephone

Exclusion criteria

  • Expecting multiple infants
  • Gestational age at baseline <12 weeks or >20 weeks
  • Unable or unwilling to agree to consume capsules until delivery
  • Unwilling to discontinue use of another prenatal supplement with DHA that contains ≥ 200 mg DHA
  • Women with allergy to any component of DHA product (including algae), soybean oil or corn oil

Treatment and study plan

Primary outcomes

  1. Infant Fat Mass (FM)

    Time frame: 24 months

    Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG

Secondary outcomes

  1. Central Fat Mass

    Time frame: 24 months

    Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: ADORE-GAINS

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 16, 2017
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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