Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation
NCT ID: NCT03310983
Last Updated: 2024-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
254 participants
OBSERVATIONAL
2017-11-01
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
* Available by telephone
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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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
Countries
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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ADORE Clinicaltrials.gov Record - Parent Study
Other Identifiers
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STUDY00140895
Identifier Type: -
Identifier Source: org_study_id
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