ClinicalTrials.gg
CompletedNCT03310983ADORE-GAINSUpdated Oct 8, 2024Results posted

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

An observational study in Pregnancy; Nutritional Diseases, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by University of Kansas Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
254
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 61 studies in Gestational Weight Gain with a site in United States — 12 open to participants now, 15 under way, none of them phase 3. Gestational Weight Gain · United States.

Started
2017
with 4 others
Observational
6 of 61
1 open now
Registered
19th of 61
by date
Lead sponsor
3 of 61
University of Kansas Medical Center

Among the 61 studies in Gestational Weight Gain with a site in United States, this one is one of 5 that started in 2017, is one of 6 observational ones, and was the 19th registered.

Gestational Weight Gain

134 studies on the registry are indexed under Gestational Weight Gain; 24 are open to participants now.

Browse Gestational Weight Gain studies →

Open to participants now

12 of the 61 studies in Gestational Weight Gain with a site in United States are open now. Recruiting first, the newest first:

7 more — sign in →

All 12 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 21 Gestational Weight Gain studies recruiting now, 7 (33%) set no upper age limit and 14 (67%) stop at 75 or younger; 4 take children under 18; 12 take healthy volunteers.

This study: 18 Years and older · female · healthy volunteers too.

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02

Study 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.

03

Conditions studied

  • Pregnancy; Nutritional Diseases

Keywords

  • Fat mass
  • Gestational weight gain
  • Fetal adipose tissue
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants are invited from those already participating in the parent study, ADORE.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Inclusion criteria

Inclusion Criteria:

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
254 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. Infant Fat Mass (FM)

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

    Time frame: 24 months

Secondary outcomes

  1. Central Fat Mass

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

    Time frame: 24 months

07

Results

Posted Oct 8, 2024

Participant flow

Participant flow — Overall Study
Milestone200 MG/DAY1000 MG/DAY
Started126128
Completed111111
Not completed1517
Withdrew: Lost to follow-up1517

Outcome measures

PrimaryInfant Fat Mass (FM)

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

Time frame:
24 months
Reported as:
Mean · g
Infant Fat Mass (FM)
g200 MG/DAY1000 MG/DAY
Infant Fat Mass (FM)3050.7 (2697.3 to 3404.1)3673.6 (3248.6 to 4098.7)
SecondaryCentral Fat Mass

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

Time frame:
24 months
Reported as:
Mean · g
Central Fat Mass
g200 MG/DAY1000 MG/DAY
Central Fat Mass1085.3 (934.3 to 1236.2)1377.3 (1195.8 to 1558.8)

Adverse events

Collected over Collected for the duration of study visits, 24 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
200 MG/DAY0/124 (0%)0/124 (0%)0/124 (0%)
1000 MG/DAY0/126 (0%)0/126 (0%)0/126 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)ADORE- 200 mg/DayADORE - 1000 mg/DayTotal
Mean30.4 ± 5.131.3 ± 5.630.9 ± 5.3
Sex: Female, Male
Sex: Female, Male(Participants)ADORE- 200 mg/DayADORE - 1000 mg/DayTotal
Female126128254
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ADORE- 200 mg/DayADORE - 1000 mg/DayTotal
Maternal Race and Ethnicity — American Indian or Alaska Native101
Maternal Race and Ethnicity — Asian055
Maternal Race and Ethnicity — Black or African American131023
Maternal Race and Ethnicity — Hispanic435396
Maternal Race and Ethnicity — White6659125
Maternal Race and Ethnicity — More than one race314
DHA mean % of RBC Total Fatty Acids
DHA mean % of RBC Total Fatty Acids(percent of total fatty acids in RBC)ADORE- 200 mg/DayADORE - 1000 mg/DayTotal
Mean6.5 ± 1.76.1 ± 1.66.3 ± 1.6
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)ADORE- 200 mg/DayADORE - 1000 mg/DayTotal
Mean28.2 ± 6.929.1 ± 8.128.7 ± 7.5
08

Study locations

1 site
  • The University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Aug 2022, 57 months.

Results were first posted in Oct 2024, 2 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2017
First posted
Oct 16, 2017
StartActual
Nov 1, 2017
Primary completionActual
Aug 31, 2022
CompletionActual
Aug 31, 2022
Results first posted
Oct 8, 2024
Last update
Oct 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03310983
Responsible party
Sponsor
First posted
Oct 16, 2017
Start date
Nov 1, 2017
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Results posted
Oct 8, 2024
Last update
Oct 8, 2024

Study contacts

Holly Hull, PhD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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