Preterm BirthPhase 3ADORENCT02626299
Assessment of DHA On Reducing Early Preterm Birth
A Phase 3 study testing Docosahexaenoic acid - 800mg/day and Docosahexaenoic acid - 200mg/day in people with Preterm Birth, run by University of Kansas Medical Center at 3 sites in United States.
Trial summary
The purpose of this study is to determine if giving a larger amount of DHA than currently included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks of pregnancy). 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
- Preterm Birth
- What is being tested?
- Docosahexaenoic acid - 800mg/day and Docosahexaenoic acid - 200mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Jun 2016to 5 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
Who may be able to join
- Pregnant females 18 years and older 12 to 20 weeks gestation at study entry
- Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
- Available by telephone
- Able to speak and read in either English or Spanish language
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 that contains greater than or equal to 200 mg DHA per day
- Women with allergy to any component of DHA product (including algae), soybean oil or corn oil
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Cincinnati
Cincinnati, Ohio, 45220
Ohio State University
Columbus, Ohio, 43210
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)
The purpose of this study is to determine if giving a larger amount of DHA than currently included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks of pregnancy).
Read the detailed description
Docosahexaenoic acid (DHA) is a nutrient found in some fish and eggs and its intake in US diets is typically low. Because DHA is important for early brain development, it has recently been added to many prenatal supplements. The usual amount is around 200 mg/day. Participants in this study are guaranteed to receive at least 200 mg/day of DHA.
Almost 5 in 100 births in the US occur before 34 weeks of pregnancy. There is no way to predict which births will occur before 34 weeks. In an earlier study conducted at the University of Kansas Medical Center, women who received 600 mg DHA/day compared to no DHA had fewer births before 34 weeks of pregnancy with fewer complications of preterm birth.
This study is designed to compare standard care (200 mg/day of DHA) to a higher amount of DHA (1000 mg/day) to determine if the higher amount will reduce early preterm birth (birth before 34 weeks of pregnancy). Individual participation in this study is expected last about 5 months.
- Conditions
- Preterm Birth
- Being tested
- Docosahexaenoic acid - 800mg/day, Docosahexaenoic acid - 200mg/day, Placebo
- Keywords
- Preterm birth, Early preterm birth, Very low birth weight, Low birth weight, Pregnancy outcome, Docosahexaenoic acid (DHA), Randomized cliinical trial, Superiority trial, Adaptive design
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic acid - 800mg/dayDrug
Also called DHA
All participants will take 1000 mg/DHA per day (1 capsule will be labeled with 200 mg; 2 capsules will be masked with 400 mg each)
Docosahexaenoic acid - 200mg/dayDrug
Also called DHA
The control group will receive 1-capsule containing 200 mg DHA/d.
PlaceboOther
Participants will receive 2 capsules (masked) containing half soybean oil and half corn oil equaling 800 mg.The soybean and corn oil combination does not contain DHA.
| Study group | Role | What they receive |
|---|---|---|
| 200 mg/day DHA | Placebo comparator | Participants will receive 2 placebo pills/day that do not contain DHA. Like the experimental group, they will be given a supplement of Docosahexaenoic acid - 200mg/day , a common amount in prenatal vitamins. Receives: Drug: Docosahexaenoic acid - 200mg/day; Other: Placebo |
| 1000 mg/day DHA | Experimental | The intervention includes Docosahexaenoic acid - 800mg/day per day provided in two 400 mg capsules. The intervention group as well as the active comparator group will be given 1-200 mg/capsule per day of DHA that is a common amount in prenatal vitamins. Receives: Drug: Docosahexaenoic acid - 800mg/day; Drug: Docosahexaenoic acid - 200mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Early Preterm Birth (<34 weeks gestation)
Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose
Measured: Baseline to 34 Weeks
Occurrence of Early Preterm Birth (<34 weeks gestation)
Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose and DHA status at enrollment (low/high) (modified statistical analysis plan while study was underway)
Measured: Baseline to 34 weeks
Maternal and infant adverse and serious adverse events
Bayesian posterior mean and 95% credible interval by dose
Measured: Enrollment to 30 days past last birth
Secondary outcomes (18)
Very low birth weight
Bayesian posterior mean and 95% credible interval <1500 grams by dose
Measured: At birth
Low birth weight
Bayesian posterior mean and 95% credible interval <2500 grams by dose
Measured: birth
Maternal and infant DHA status
Bayesian posterior mean and 95% credible interval red blood cell phospholipid DHA (weight percent of total fatty acids) at enrollment and birth by dose
Measured: birth
Gestational age
Bayesian posterior mean and 95% credible interval weeks gestation at birth by dose
Measured: birth
Birth weight
Bayesian posterior mean and 95% credible interval in grams by dose
Measured: birth
Length and head circumference
Bayesian posterior mean and 95% credible interval in centimeters by dose
Measured: birth
Preterm birth (<37 weeks)
Bayesian posterior mean and 95% credible interval in weeks by dose
Measured: birth
Preterm birth (<37 weeks)
Number of pregnancies ending in preterm birth by dose
Measured: birth
Pre-eclampsia
Bayesian posterior mean and 95% credible interval
Measured: 12-20 weeks gestation through birth at an average of 40 weeks
Pre-eclampsia
Number of patients with pre-eclampsia by dose
Measured: 12-20 weeks gestation through birth at an average of 40 weeks
Gestational diabetes
Bayesian posterior mean and 95% credible interval by dose
Measured: 12-20 weeks gestation through birth at an average of 40 weeks
Gestational diabetes
Number of patients with gestational diabetes by dose
Measured: 12-20 weeks gestation through birth at an average of 40 weeks
Cesarean section
Bayesian posterior mean and 95% credible interval by dose
Measured: birth
Cesarean section
Number of patients with c-section by dose
Measured: birth
Spontaneous labor
Bayesian posterior mean and 95% credible interval by dose
Measured: birth
Spontaneous labor
Number of patients with spontaneous labor by dose
Measured: birth
Admissiion of neonate to a neonatal intensive care unit
Bayesian posterior mean and 95% credible interval by dose
Measured: birth
Admissiion of neonate to a neonatal intensive care unit
Number of neonates admited to a neonatal intensive care unit by dose
Measured: birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start8 Jun 2016
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Carlson, PhD, University of Kansas Medical Center
- Investigators
- Susan E. Carlson, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626299
- Sponsor's protocol ID
- STUDY00003455
- Acronym
- ADORE
- Status last verified
- Mar 2021
- First submitted
- 8 Dec 2015
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li YN, Kothapalli KSD, Carlson SE, Gajewski BJ, DeFranco EA, Brenna JT. Genotype-informed docosahexaenoic acid dosing based on the FADS Indel to reduce preterm and prolonged gestation: A secondary analysis of the ADORE randomized trial. PLoS Med. 2026 Oct 8;23(10):e1005274. doi: 10.1371/journal.pmed.1005274. Online ahead of print.
PubMed 42848825Wang Y, Gajewski BJ, Valentine CJ, Crawford SA, Brown AR, Mudaranthakam DP, Camargo JT, Carlson SE. DHA, nutrient intake, and maternal characteristics as predictors of pregnancy outcomes in a randomised clinical trial of DHA supplementation. Clin Nutr. 2023 Nov;42(11):2229-2240. doi: 10.1016/j.clnu.2023.09.005. Epub 2023 Sep 20.
PubMed 37806075Carlson SE, Gajewski BJ, Valentine CJ, Sands SA, Brown AR, Kerling EH, Crawford SA, Buhimschi CS, Weiner CP, Cackovic M, DeFranco EA, Mudaranthakam DP, Rogers LK. Early and late preterm birth rates in participants adherent to randomly assigned high dose docosahexaenoic acid (DHA) supplementation in pregnancy. Clin Nutr. 2023 Feb;42(2):235-243. doi: 10.1016/j.clnu.2023.01.009. Epub 2023 Jan 11.
PubMed 36680919Mudaranthakam DP, Brown A, Kerling E, Carlson SE, Valentine CJ, Gajewski B. The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study. JMIR Form Res. 2021 Dec 22;5(12):e30368. doi: 10.2196/30368.
PubMed 34941552Carlson SE, Gajewski BJ, Valentine CJ, Kerling EH, Weiner CP, Cackovic M, Buhimschi CS, Rogers LK, Sands SA, Brown AR, Mudaranthakam DP, Crawford SA, DeFranco EA. Higher dose docosahexaenoic acid supplementation during pregnancy and early preterm birth: A randomised, double-blind, adaptive-design superiority trial. EClinicalMedicine. 2021 May 17;36:100905. doi: 10.1016/j.eclinm.2021.100905. eCollection 2021 Jun.
PubMed 34308309Carlson SE, Gajewski BJ, Valentine CJ, Rogers LK, Weiner CP, DeFranco EA, Buhimschi CS. Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol. BMC Pregnancy Childbirth. 2017 Feb 13;17(1):62. doi: 10.1186/s12884-017-1244-5.
PubMed 28193189
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)
- ClinicalTrials.gov ID
- NCT02626299
- Acronym / sponsor ID
- ADORE / STUDY00003455
- Conditions
- Preterm Birth
- Keywords
- Preterm birth, Early preterm birth, Very low birth weight, Low birth weight, Pregnancy outcome, Docosahexaenoic acid (DHA), Randomized cliinical trial, Superiority trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- University of Cincinnati, Ohio State University, Nationwide Children's Hospital
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
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 determine if giving a larger amount of DHA than currently included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks of pregnancy).
Detailed description
Docosahexaenoic acid (DHA) is a nutrient found in some fish and eggs and its intake in US diets is typically low. Because DHA is important for early brain development, it has recently been added to many prenatal supplements. The usual amount is around 200 mg/day. Participants in this study are guaranteed to receive at least 200 mg/day of DHA.
Almost 5 in 100 births in the US occur before 34 weeks of pregnancy. There is no way to predict which births will occur before 34 weeks. In an earlier study conducted at the University of Kansas Medical Center, women who received 600 mg DHA/day compared to no DHA had fewer births before 34 weeks of pregnancy with fewer complications of preterm birth.
This study is designed to compare standard care (200 mg/day of DHA) to a higher amount of DHA (1000 mg/day) to determine if the higher amount will reduce early preterm birth (birth before 34 weeks of pregnancy). Individual participation in this study is expected last about 5 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 200 mg/day DHA | Placebo comparator | Drug: Docosahexaenoic acid - 200mg/day, Other: PlaceboParticipants will receive 2 placebo pills/day that do not contain DHA. Like the experimental group, they will be given a supplement of Docosahexaenoic acid - 200mg/day , a common amount in prenatal vitamins. |
| 1000 mg/day DHA | Experimental | Drug: Docosahexaenoic acid - 800mg/day, Drug: Docosahexaenoic acid - 200mg/dayThe intervention includes Docosahexaenoic acid - 800mg/day per day provided in two 400 mg capsules. The intervention group as well as the active comparator group will be given 1-200 mg/capsule per day of DHA that is a common amount in prenatal vitamins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant females 18 years and older 12 to 20 weeks gestation at study entry
- Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
- Available by telephone
- Able to speak and read in either English or Spanish language
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 that contains greater than or equal to 200 mg DHA per day
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docosahexaenoic acid - 800mg/dayAlso: DHAAll participants will take 1000 mg/DHA per day (1 capsule will be labeled with 200 mg; 2 capsules will be masked with 400 mg each) | Drug | 1000 mg/day DHA |
| Docosahexaenoic acid - 200mg/dayAlso: DHAThe control group will receive 1-capsule containing 200 mg DHA/d. | Drug | 1000 mg/day DHA, 200 mg/day DHA |
| PlaceboParticipants will receive 2 capsules (masked) containing half soybean oil and half corn oil equaling 800 mg.The soybean and corn oil combination does not contain DHA. | Other | 200 mg/day DHA |
Primary outcome
Occurrence of Early Preterm Birth (<34 weeks gestation)
Time frame: Baseline to 34 Weeks
Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose
Occurrence of Early Preterm Birth (<34 weeks gestation)
Time frame: Baseline to 34 weeks
Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose and DHA status at enrollment (low/high) (modified statistical analysis plan while study was underway)
Maternal and infant adverse and serious adverse events
Time frame: Enrollment to 30 days past last birth
Bayesian posterior mean and 95% credible interval by dose
18 secondary outcomes
Very low birth weight
Time frame: At birth
Low birth weight
Time frame: birth
Maternal and infant DHA status
Time frame: birth
Gestational age
Time frame: birth
Birth weight
Time frame: birth
Length and head circumference
Time frame: birth
Preterm birth (<37 weeks)
Time frame: birth
Preterm birth (<37 weeks)
Time frame: birth
Pre-eclampsia
Time frame: 12-20 weeks gestation through birth at an average of 40 weeks
Pre-eclampsia
Time frame: 12-20 weeks gestation through birth at an average of 40 weeks
Gestational diabetes
Time frame: 12-20 weeks gestation through birth at an average of 40 weeks
Gestational diabetes
Time frame: 12-20 weeks gestation through birth at an average of 40 weeks
Cesarean section
Time frame: birth
Cesarean section
Time frame: birth
Spontaneous labor
Time frame: birth
Spontaneous labor
Time frame: birth
Admissiion of neonate to a neonatal intensive care unit
Time frame: birth
Admissiion of neonate to a neonatal intensive care unit
Time frame: birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 42848825Li YN, Kothapalli KSD, Carlson SE, Gajewski BJ, DeFranco EA, Brenna JT. Genotype-informed docosahexaenoic acid dosing based on the FADS Indel to reduce preterm and prolonged gestation: A secondary analysis of the ADORE randomized trial. PLoS Med. 2026 Oct 8;23(10):e1005274. doi: 10.1371/journal.pmed.1005274. Online ahead of print.
- Derived from this study: PubMed 37806075Wang Y, Gajewski BJ, Valentine CJ, Crawford SA, Brown AR, Mudaranthakam DP, Camargo JT, Carlson SE. DHA, nutrient intake, and maternal characteristics as predictors of pregnancy outcomes in a randomised clinical trial of DHA supplementation. Clin Nutr. 2023 Nov;42(11):2229-2240. doi: 10.1016/j.clnu.2023.09.005. Epub 2023 Sep 20.
- Derived from this study: PubMed 36680919Carlson SE, Gajewski BJ, Valentine CJ, Sands SA, Brown AR, Kerling EH, Crawford SA, Buhimschi CS, Weiner CP, Cackovic M, DeFranco EA, Mudaranthakam DP, Rogers LK. Early and late preterm birth rates in participants adherent to randomly assigned high dose docosahexaenoic acid (DHA) supplementation in pregnancy. Clin Nutr. 2023 Feb;42(2):235-243. doi: 10.1016/j.clnu.2023.01.009. Epub 2023 Jan 11.
- Derived from this study: PubMed 34941552Mudaranthakam DP, Brown A, Kerling E, Carlson SE, Valentine CJ, Gajewski B. The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study. JMIR Form Res. 2021 Dec 22;5(12):e30368. doi: 10.2196/30368.
- Derived from this study: PubMed 34308309Carlson SE, Gajewski BJ, Valentine CJ, Kerling EH, Weiner CP, Cackovic M, Buhimschi CS, Rogers LK, Sands SA, Brown AR, Mudaranthakam DP, Crawford SA, DeFranco EA. Higher dose docosahexaenoic acid supplementation during pregnancy and early preterm birth: A randomised, double-blind, adaptive-design superiority trial. EClinicalMedicine. 2021 May 17;36:100905. doi: 10.1016/j.eclinm.2021.100905. eCollection 2021 Jun.
- Derived from this study: PubMed 28193189Carlson SE, Gajewski BJ, Valentine CJ, Rogers LK, Weiner CP, DeFranco EA, Buhimschi CS. Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol. BMC Pregnancy Childbirth. 2017 Feb 13;17(1):62. doi: 10.1186/s12884-017-1244-5.
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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.
Susan E. Carlson, PhD principal investigator
University of Kansas Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docosahexaenoic acid - 800mg/day and Docosahexaenoic acid - 200mg/day in people with Preterm Birth, run by University of Kansas Medical Center at 3 sites 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 4 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of Early Preterm Birth (<34 weeks gestation) (time frame: Baseline to 34 Weeks). The study lists 3 primary outcomes in all. 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 NCT02626299, which also lists 6 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 30 Mar 2021.