PregnancyPhase 3NCT01007110
Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
A Phase 3 study testing DHA in people with Pregnancy, run by University of Kansas at 1 site in United States.
Trial summary
DHA, a type of fatty acid, is important in early development, both in terms of reproductive physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA has been shown to lower triglycerides and is important to cardiovascular health and autonomic control, lowering heart rate and blood… Read more about this study
- Who is it for?
- Ages 16 to 35 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- DHA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jul 2011
- Phase
- Phase 3
- 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 16 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant females 16.0-35.99 years of age who are 12 to 20 weeks gestation at the time of enrollment (by dates or ultrasound)
- Agree to consume study capsules from enrollment until delivery
- BMI <40 at baseline or weight does not exceed 300 pounds
- No serious illnesses likely to confound study outcomes
- Available by phone
Who cannot join
- Less than 16 or greater than 35.99 years of age at enrollment
- BMI >40 at baseline
- Any serious illness likely to confound primary study outcomes
- Expecting multiple infants
- Diabetes (Type I, II or gestational) at baseline
- Elevated blood pressure due to any cause (systolic BP >= 140 mm Hg
- Gestational age at baseline < 12 weeks or > 20 weeks
- Unable to provide informed consent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: The Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
DHA, a type of fatty acid, is important in early development, both in terms of reproductive physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA has been shown to lower triglycerides and is important to cardiovascular health and autonomic control, lowering heart rate and blood pressure and increasing heart variability. Little is known about how fatty acids impact cardiac control in infants, children or the fetus. Our hypothesis is that maternal DHA supplementation (600 mg/day) will lower fetal HR and increase fetal HRV.
Read the detailed description
We have observed that maternal DHA supplementation during pregnancy results in lower fetal heart rate (HR) and higher heart-rate variability (HRV). In another study, we found that infants on DHA supplemented formula have lower HR. Because DHA supplementation in infancy is associated with improved neurobehavioral outcomes and infants with lower HR and higher vagal control have been found to have improved developmental outcomes, the first aim is to conduct a randomized, placebo-controlled trial to determine whether maternal DHA supplementation during pregnancy results in lower HR and higher HRV in the fetal period. We will document other fetal neurobehaviors (body and breathing movements) as they are hallmarks of fetal well-being and influence HR and HRV.
- Conditions
- Pregnancy
- Being tested
- DHA, Placebo
- Keywords
- DHA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHADietary supplement
Also called Docosahexaenoic acid
Docosahexaenoic Acid (DHA) from algal oil
PlaceboOther
Also called Algal oil
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Docosahexaenoic Acid (DHA) | Active comparator | Docosahexaenoic Acid (DHA) Receives: Dietary Supplement: DHA |
| Placebo | Placebo comparator | soy/corn oil placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.
Measured: 24, 32 and 36 weeks gestational age
Secondary outcomes (4)
Neonatal Behavioral Assessment Scale (NBAS) Scores
The Neonatal Behavioral Assessment Scale (NBAS) measure 6 areas.
For behavioral items a higher score corresponds to more desirable outcomes:
- Habituation: Sum of scores across 3 items, scored on a scale of 1-9. Range: 3-27.
- Orientation: Sum of scores across 7 items, scored on a scale of 1-9. Range: 7 - 63.
- Motor: Sum of scores across 5 items; 3 scored on a scale of 1-9, 1 scored on a scale of 1-6, and 1 scored on a scale of 1-5. Range: 5-38.
- Range of State: Sum of scores across 4 items; 2 scored on a scale of 1-6 and 2 scored on a scale of 1-5. Range: 4-22.
- Regulation of State: Sum of scores across 4 items, scored on a scale of 1-9. Range: is 4-36.
- Autonomic Stability: Sum of scores across 3 items; 1 scored on a scale of 1-9, 1 on a scale of 1-8, and 1 on a scale of 1-6. Range: 3-23.
Reflexes: Sum across the 18 items, scored on a scale of 0-3. Range: 0 to 54. The supplementary items are each scored on a scale of 1-9 and do not combine to form a composite.
Measured: within 2 weeks of delivery
Maternal Red Blood Cell (RBC) Phospholipids at Delivery
Maternal red blood cell phospholipid collected at delivery. These results were compared to baseline red blood cell phospholipid that was collected at study enrollment. A weighed standard fatty acid mixture (Supelco 37 component fatty acid methyl ester mix,Sigma Aldrich) was employed to correct final DHA weight percent of total fatty acids (wt%TFA).
Measured: Time of delivery, 36 weeks to term
Cord Blood Phospholipids DHA
Newborn red blood cell phospholipids collected at birth.
Measured: Birth
Cardiac Conduction Time
Measured: Change from Baseline to 2 Months Post-natal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2011
- Study completionJul 2011
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 (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Gustafson, Ph.D., University of Kansas
- Investigators
- Kathleen Gustafson, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007110
- Sponsor's protocol ID
- 11625
- Status last verified
- Jun 2014
- First submitted
- 2 Nov 2009
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gustafson KM, Carlson SE, Colombo J, Yeh HW, Shaddy DJ, Li S, Kerling EH. Effects of docosahexaenoic acid supplementation during pregnancy on fetal heart rate and variability: a randomized clinical trial. Prostaglandins Leukot Essent Fatty Acids. 2013 May;88(5):331-8. doi: 10.1016/j.plefa.2013.01.009. Epub 2013 Feb 20.
PubMed 23433688Christifano DN, Taylor MK, Carlson SE, Colombo J, Gustafson KM. Higher maternal weight is related to poorer fetal autonomic function. J Dev Orig Health Dis. 2021 Jun;12(3):354-356. doi: 10.1017/S2040174420000653. Epub 2020 Jul 14.
PubMed 32662379Hoyer D, Schmidt A, Gustafson KM, Lobmaier SM, Lakhno I, van Leeuwen P, Cysarz D, Preisl H, Schneider U. Heart rate variability categories of fluctuation amplitude and complexity: diagnostic markers of fetal development and its disturbances. Physiol Meas. 2019 Jul 3;40(6):064002. doi: 10.1088/1361-6579/ab205f.
PubMed 31071684
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
- ClinicalTrials.gov ID
- NCT01007110
- Acronym / sponsor ID
- 11625
- Conditions
- Pregnancy
- Keywords
- DHA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Posted 14 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DHA, a type of fatty acid, is important in early development, both in terms of reproductive physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA has been shown to lower triglycerides and is important to cardiovascular health and autonomic control, lowering heart rate and blood pressure and increasing heart variability. Little is known about how fatty acids impact cardiac control in infants, children or the fetus. Our hypothesis is that maternal DHA supplementation (600 mg/day) will lower fetal HR and increase fetal HRV.
Detailed description
We have observed that maternal DHA supplementation during pregnancy results in lower fetal heart rate (HR) and higher heart-rate variability (HRV). In another study, we found that infants on DHA supplemented formula have lower HR. Because DHA supplementation in infancy is associated with improved neurobehavioral outcomes and infants with lower HR and higher vagal control have been found to have improved developmental outcomes, the first aim is to conduct a randomized, placebo-controlled trial to determine whether maternal DHA supplementation during pregnancy results in lower HR and higher HRV in the fetal period. We will document other fetal neurobehaviors (body and breathing movements) as they are hallmarks of fetal well-being and influence HR and HRV.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docosahexaenoic Acid (DHA) | Active comparator | Dietary Supplement: DHADocosahexaenoic Acid (DHA) |
| Placebo | Placebo comparator | Other: Placebosoy/corn oil placebo |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Pregnant females 16.0-35.99 years of age who are 12 to 20 weeks gestation at the time of enrollment (by dates or ultrasound)
- Agree to consume study capsules from enrollment until delivery
- BMI <40 at baseline or weight does not exceed 300 pounds
- No serious illnesses likely to confound study outcomes
- Available by phone
Key exclusion criteria (8 listed)
- Less than 16 or greater than 35.99 years of age at enrollment
- BMI >40 at baseline
- Any serious illness likely to confound primary study outcomes
- Expecting multiple infants
- Diabetes (Type I, II or gestational) at baseline
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 |
|---|---|---|
| DHAAlso: Docosahexaenoic acidDocosahexaenoic Acid (DHA) from algal oil | Dietary supplement | Docosahexaenoic Acid (DHA) |
| PlaceboAlso: Algal oilPlacebo capsule | Other | Placebo |
Primary outcome
Heart Rate
Time frame: 24, 32 and 36 weeks gestational age
Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.
4 secondary outcomes
Neonatal Behavioral Assessment Scale (NBAS) Scores
Time frame: within 2 weeks of delivery
Maternal Red Blood Cell (RBC) Phospholipids at Delivery
Time frame: Time of delivery, 36 weeks to term
Cord Blood Phospholipids DHA
Time frame: Birth
Cardiac Conduction Time
Time frame: Change from Baseline to 2 Months Post-natal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23433688Gustafson KM, Carlson SE, Colombo J, Yeh HW, Shaddy DJ, Li S, Kerling EH. Effects of docosahexaenoic acid supplementation during pregnancy on fetal heart rate and variability: a randomized clinical trial. Prostaglandins Leukot Essent Fatty Acids. 2013 May;88(5):331-8. doi: 10.1016/j.plefa.2013.01.009. Epub 2013 Feb 20.
- Derived from this study: PubMed 32662379Christifano DN, Taylor MK, Carlson SE, Colombo J, Gustafson KM. Higher maternal weight is related to poorer fetal autonomic function. J Dev Orig Health Dis. 2021 Jun;12(3):354-356. doi: 10.1017/S2040174420000653. Epub 2020 Jul 14.
- Derived from this study: PubMed 31071684Hoyer D, Schmidt A, Gustafson KM, Lobmaier SM, Lakhno I, van Leeuwen P, Cysarz D, Preisl H, Schneider U. Heart rate variability categories of fluctuation amplitude and complexity: diagnostic markers of fetal development and its disturbances. Physiol Meas. 2019 Jul 3;40(6):064002. doi: 10.1088/1361-6579/ab205f.
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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.
Kathleen Gustafson, 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?
A Phase 3 study testing DHA in people with Pregnancy, run by University of Kansas 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 5 inclusion and 8 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 9 Jun 2014. 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. 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?
Yes. Results are posted in the registry (first posted 14 May 2014). 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?
Heart Rate (time frame: 24, 32 and 36 weeks gestational age). 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 NCT01007110, which also lists 3 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 9 Jun 2014.