NCT03310983: ADORE-GAINS

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

Completed Results posted Last updated 8 October 2024

What this trial tests

trial in Pregnancy; Nutritional Diseases in 254 participants. Completed in 31 August 2022.

Timeline

1 November 2017

Primary endpoint
31 August 2022

31 August 2022

Quick facts

Lead sponsor	University of Kansas Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	254
Start date	1 November 2017
Primary completion	31 August 2022
Estimated completion	31 August 2022
Sites	1 location across United States

Conditions studied

• Pregnancy; Nutritional Diseases — all drugs for Pregnancy; Nutritional Diseases →

Sponsor

University of Kansas Medical Center

Who can join

18 and older, female only, with Pregnancy; Nutritional Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Infant Fat Mass (FM) Primary · 24 months

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

Group	Value	95% CI
200 MG/DAY	3050.7	2697.3 – 3404.1
1000 MG/DAY	3673.6	3248.6 – 4098.7

Central Fat Mass Secondary · 24 months

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

Group	Value	95% CI
200 MG/DAY	1085.3	934.3 – 1236.2
1000 MG/DAY	1377.3	1195.8 – 1558.8

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of vitamin and mineral supplementation during pregnancy on maternal, birth, child health and development outcomes in low- and middle-income countries: A systematic review.
   Keats EC, Oh C, Chau T, Khalifa DS, et al · · 2021 · cited 22× · PMID 37051178 · DOI 10.1002/cl2.1127
2. The Effect of Prenatal Docosahexaenoic Acid Supplementation on Offspring Fat Mass and Distribution at 24 Months Old.
   Hull HR, Brown A, Gajewski B, Sullivan DK, et al · · 2024 · cited 3× · PMID 38948108 · DOI 10.1016/j.cdnut.2024.103771
3. Growth and adiposity in newborns study (GAINS): The influence of prenatal DHA supplementation protocol.
   Hull HR, Gajewski BJ, Sullivan DK, Carson SE. · · 2023 · cited 3× · PMID 37406769 · DOI 10.1016/j.cct.2023.107279
4. Ethnicity modifies the relationship between added sugars and fructose exposure in the first 1000 days and offspring body composition at 24 months.
   Fortin-Miller SA, Gajewski BJ, Carlson SE, Colombo JA, et al · · 2025 · PMID 40381608 · DOI 10.1016/j.nutres.2025.04.009