Pregnancy; Nutritional DiseasesADORE-GAINSNCT03310983
Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation
An observational study of Pregnancy; Nutritional Diseases, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy; Nutritional Diseases
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 31 Aug 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are invited from those already participating in the parent study, ADORE.
Who may be able to join
- Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
- Available by telephone
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Pregnancy; Nutritional Diseases
- Keywords
- Fat mass, Gestational weight gain, Fetal adipose tissue
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Fat Mass (FM)
Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Nov 2017
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy; Nutritional DiseasesStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly Hull, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310983
- Sponsor's protocol ID
- STUDY00140895
- Acronym
- ADORE-GAINS
- Status last verified
- May 2024
- First submitted
- 10 Oct 2017
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38948108Hull 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.
PubMed 37406769
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation
- ClinicalTrials.gov ID
- NCT03310983
- Acronym / sponsor ID
- ADORE-GAINS / STUDY00140895
- Conditions
- Pregnancy; Nutritional Diseases
- Keywords
- Fat mass, Gestational weight gain, Fetal adipose tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are invited from those already participating in the parent study, ADORE.
Key inclusion criteria (2 listed)
- Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
- Available by telephone
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infant Fat Mass (FM)
Time frame: 24 months
Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG
1 secondary outcome
Central Fat Mass
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38948108Hull 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.
- Derived from this study: PubMed 37406769Hull 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.
- ADORE Clinicaltrials.gov Record - Parent StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Hull, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy; Nutritional Diseases, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Fat Mass (FM) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03310983, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.