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

NCT ID: NCT03310983

Last Updated: 2024-10-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

254 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy; Nutritional Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ADORE- 200 mg/day

Participants enrolled in the ADORE study that were randomly assigned to the 200 mg/day group that consented to participate in ADORE-GAINS.

No interventions assigned to this group

ADORE - 1000 mg/day

Participants enrolled in the ADORE study that were randomly assigned to the 1000 mg/day group that consented to participate in ADORE-GAINS.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holly Hull, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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The University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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Hull HR, Brown A, Gajewski B, Sullivan DK, Carlson SE. The Effect of Prenatal Docosahexaenoic Acid Supplementation on Offspring Fat Mass and Distribution at 24 Months Old. Curr Dev Nutr. 2024 May 11;8(6):103771. doi: 10.1016/j.cdnut.2024.103771. eCollection 2024 Jun.

Reference Type DERIVED
PMID: 38948108 (View on PubMed)

Hull HR, Gajewski BJ, Sullivan DK, Carson SE. Growth and adiposity in newborns study (GAINS): The influence of prenatal DHA supplementation protocol. Contemp Clin Trials. 2023 Sep;132:107279. doi: 10.1016/j.cct.2023.107279. Epub 2023 Jul 3.

Reference Type DERIVED
PMID: 37406769 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://clinicaltrials.gov/ct2/show/NCT02626299

ADORE Clinicaltrials.gov Record - Parent Study

Other Identifiers

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STUDY00140895

Identifier Type: -

Identifier Source: org_study_id

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