PregnancyNCT02219399
DHA Supplementation and Pregnancy Outcome
A study testing 600 mg DHA and 300 mg DHA in people with Pregnancy, run by Colorado State University at 2 sites in United States.
Trial summary
Supplementation with DHA during pregnancy will increase gestational length and improve cognitive development. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- 600 mg DHA and 300 mg DHA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 871 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2001to Jan 2014
- Phase
- Interventional
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton pregnancy
- 18 years of age or older
Who cannot join
- cervical incompetence
- presence of cervical cerclage
- placenta previa
- intrauterine infection
- known substance abuse
- multiple fetuses
- current pre-eclampsia
- preexisting diabetes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Denver Health Hospitals and Clinics
Denver, Colorado, 80237
Colorado State University
Fort Collins, Colorado, 80523
About this study
Official title: Maternal DHA Supplementation and Pregnancy Outcome
Supplementation with DHA during pregnancy will increase gestational length and improve cognitive development.
Read the detailed description
This was a trial of supplementation with DHA during pregnancy to increase gestational length. Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data were collected and infants growth at 2 and 4 months and cognitive development at 4 months and 1 year were measured.
- Conditions
- Pregnancy
- Being tested
- 600 mg DHA, 300 mg DHA, Placebo
- Keywords
- Pregnancy, DHA, Gestational Length, Cognitive Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
600 mg DHADietary supplement
Pregnant women were given 600 mg DHA in the last trimester of pregnancy
300 mg DHADietary supplement
Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding
PlaceboDietary supplement
Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period
| Study group | Role | What they receive |
|---|---|---|
| 300 mg DHA | Experimental | 300 mg DHA Receives: Dietary Supplement: 300 mg DHA |
| Placebo | Placebo comparator | olive oil or high oleic acid sunflower oil placebo Receives: Dietary Supplement: Placebo |
| 600 mg DHA | Experimental | 600 mg DHA Receives: Dietary Supplement: 600 mg DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Length
Length of gestation as measured by Last menstrual period method and US
Measured: 13 weeks
Cognitive Development
Bayley's Scales of Infant Development measured at 4 months of age
Measured: 4 months
Cognitive Development
Bayley's Scales of Infant Development measured at 12 months of age
Measured: 12 months
Secondary outcomes (4)
Infant birth length
self-explanatory
Measured: 13 weeks
Infant Growth Velocity
Change in infant length and weight from 2 to 4 months of age
Measured: 2 months to 4 months of age
Infant birth weight
self-explanatory
Measured: 13 weeks
Infant head circumference at birth
self-explanatory
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startJan 2001
- Primary completionJan 2004
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Responsible party
- Sponsor
- Investigators
- Mary A Harris, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219399
- Sponsor's protocol ID
- 00186H
- Status last verified
- Aug 2014
- First submitted
- 9 Jun 2014
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal DHA Supplementation and Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT02219399
- Acronym / sponsor ID
- 00186H
- Conditions
- Pregnancy
- Keywords
- Pregnancy, DHA, Gestational Length, Cognitive Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Study start
- Jan 2001
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Aug 2014 (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.
Supplementation with DHA during pregnancy will increase gestational length and improve cognitive development.
Detailed description
This was a trial of supplementation with DHA during pregnancy to increase gestational length. Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data were collected and infants growth at 2 and 4 months and cognitive development at 4 months and 1 year were measured.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 300 mg DHA | Experimental | Dietary Supplement: 300 mg DHA300 mg DHA |
| Placebo | Placebo comparator | Dietary Supplement: Placeboolive oil or high oleic acid sunflower oil placebo |
| 600 mg DHA | Experimental | Dietary Supplement: 600 mg DHA600 mg DHA |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- singleton pregnancy
- 18 years of age or older
Key exclusion criteria (8 listed)
- cervical incompetence
- presence of cervical cerclage
- placenta previa
- intrauterine infection
- known substance abuse
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 |
|---|---|---|
| 600 mg DHAPregnant women were given 600 mg DHA in the last trimester of pregnancy | Dietary supplement | 600 mg DHA |
| 300 mg DHAPregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding | Dietary supplement | 300 mg DHA |
| PlaceboPregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period | Dietary supplement | Placebo |
Primary outcome
Gestational Length
Time frame: 13 weeks
Length of gestation as measured by Last menstrual period method and US
Cognitive Development
Time frame: 4 months
Bayley's Scales of Infant Development measured at 4 months of age
Cognitive Development
Time frame: 12 months
Bayley's Scales of Infant Development measured at 12 months of age
4 secondary outcomes
Infant birth length
Time frame: 13 weeks
Infant Growth Velocity
Time frame: 2 months to 4 months of age
Infant birth weight
Time frame: 13 weeks
Infant head circumference at birth
Time frame: 13 weeks
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 18 Aug 2014.
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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.
Mary A Harris, PhD principal investigator
Colorado State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 600 mg DHA and 300 mg DHA in people with Pregnancy, run by Colorado State University at 2 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 2 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 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Gestational Length (time frame: 13 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?
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 18 Aug 2014.