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

Pregnancy; Nutritional Diseases Clinical Trial

— ADORE-GAINS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03310983
• Other study ID #: STUDY00140895
• Status: Active, not recruiting
• Start date: November 1, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 254
• Est. completion date: June 30, 2024
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nutrition Disorders
• Pregnancy; Nutritional Diseases

Intervention

Dietary Supplement:
• Docosahexaenoic acid
The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study.

Locations

Country	Name	City	State
United States	The University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Fat Mass (FM)	Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG	24 months
Secondary	Central Fat Mass	Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG	24 months

External Links

•   ADORE Clinicaltrials.gov Record - Parent Study