Preterm DeliveryNCT01353807
Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health
A study testing Fish oil and Olive oil in people with Preterm Delivery and Atopy, run by Centre for Fetal Programming, Denmark at 1 site in Denmark.
Trial summary
The aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant women, while they were in gestational week 30, were randomized to fish oil supplements providing the mentioned amount of long chain n-3… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Delivery, Atopy, Metabolic Syndrome
- What is being tested?
- Fish oil and Olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 533 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 1989to May 2011
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women in gestation week 30
Who cannot join
- Bleeding episodes during pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant women, while they were in gestational week 30, were randomized to fish oil supplements providing the mentioned amount of long chain n-3 fatty acids, olive oil supplements, or no supplements; they were asked to take the supplements until delivery. Health outcomes were assessed during pregnancy and delivery. Further, offspring health and development has been examined during the ensuring two decades by making linkages to the rich Danish health and administrative registries, by asking the offspring to complete web-based questionnaires, and by examining the offspring physically.
- Conditions
- Preterm Delivery, Atopy, Metabolic Syndrome
- Being tested
- Fish oil, Olive oil
- Keywords
- Fish oil, Pregnancy, RCT, Birth weight, Gestational age, Asthma and allergies, Metabolic syndrome, Obesity
- Medical subject headings
- Premature Birth, Metabolic Syndrome, Birth Weight, Asthma, Hypersensitivity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary supplement
Also called Pikasol
4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids
Olive oilDietary supplement
4 1-g gelatine capsules with virgin olive oil
| Study group | Role | What they receive |
|---|---|---|
| Fish oil supplementation | Active comparator | These women received 4 1-g capsules of fish oil per day providing 2,7 grams long chain n-3 fatty acids per day, from gestation week 30 until delivery Receives: Dietary Supplement: Fish oil |
| Olive oil | Placebo comparator | These women received 4 1-g capsules with olive oil per day from gestational week 30 until delivery Receives: Dietary Supplement: Olive oil |
| No oil supplement | No intervention | These women received no capsules with oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestation length
We assesed impact of fish oil supplementation in pregnancy on timing of spontaneous delivery
Measured: 1989-1990 (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startNov 1989
- Primary completionDec 1990
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preterm DeliveryStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Fetal Programming, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), The Danish Council for Strategic Research, Danish Council for Independent Research, Lundbech Foundation, EU Commision, DG12
- Investigators
- Sjurdur F. Olsen, MD, Principal investigator, Statens Serum Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353807
- Sponsor's protocol ID
- M-AA-20060182
- Other IDs
- R21AT004603
- Status last verified
- Feb 2014
- First submitted
- 29 Apr 2011
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olsen SF, Sorensen JD, Secher NJ, Hedegaard M, Henriksen TB, Hansen HS, Grant A. Randomised controlled trial of effect of fish-oil supplementation on pregnancy duration. Lancet. 1992 Apr 25;339(8800):1003-7. doi: 10.1016/0140-6736(92)90533-9.
PubMed 1349049Olsen SF, Osterdal ML, Salvig JD, Mortensen LM, Rytter D, Secher NJ, Henriksen TB. Fish oil intake compared with olive oil intake in late pregnancy and asthma in the offspring: 16 y of registry-based follow-up from a randomized controlled trial. Am J Clin Nutr. 2008 Jul;88(1):167-75. doi: 10.1093/ajcn/88.1.167.
PubMed 18614738Rytter D, Bech BH, Christensen JH, Schmidt EB, Henriksen TB, Olsen SF. Intake of fish oil during pregnancy and adiposity in 19-y-old offspring: follow-up on a randomized controlled trial. Am J Clin Nutr. 2011 Sep;94(3):701-8. doi: 10.3945/ajcn.111.014969. Epub 2011 Jul 20.
PubMed 21775563Rytter D, Schmidt EB, Bech BH, Christensen JH, Henriksen TB, Olsen SF. Fish oil supplementation during late pregnancy does not influence plasma lipids or lipoprotein levels in young adult offspring. Lipids. 2011 Dec;46(12):1091-9. doi: 10.1007/s11745-011-3606-5. Epub 2011 Aug 27.
PubMed 21874272Rytter D, Christensen JH, Bech BH, Schmidt EB, Henriksen TB, Olsen SF. The effect of maternal fish oil supplementation during the last trimester of pregnancy on blood pressure, heart rate and heart rate variability in the 19-year-old offspring. Br J Nutr. 2012 Oct 28;108(8):1475-83. doi: 10.1017/S0007114511006799. Epub 2012 Feb 7.
PubMed 22313729
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health
- ClinicalTrials.gov ID
- NCT01353807
- Acronym / sponsor ID
- M-AA-20060182
- Conditions
- Preterm Delivery, Atopy, Metabolic Syndrome
- Keywords
- Fish oil, Pregnancy, RCT, Birth weight, Gestational age, Asthma and allergies, Metabolic syndrome, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- Centre for Fetal Programming, DenmarkUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), The Danish Council for Strategic Research, Danish Council for Independent Research, Lundbech Foundation, EU Commision, DG12
- Study start
- Nov 1989
- Primary completion
- Dec 1990 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 May 2011 (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 aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant women, while they were in gestational week 30, were randomized to fish oil supplements providing the mentioned amount of long chain n-3 fatty acids, olive oil supplements, or no supplements; they were asked to take the supplements until delivery. Health outcomes were assessed during pregnancy and delivery. Further, offspring health and development has been examined during the ensuring two decades by making linkages to the rich Danish health and administrative registries, by asking the offspring to complete web-based questionnaires, and by examining the offspring physically.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fish oil supplementation | Active comparator | Dietary Supplement: Fish oilThese women received 4 1-g capsules of fish oil per day providing 2,7 grams long chain n-3 fatty acids per day, from gestation week 30 until delivery |
| Olive oil | Placebo comparator | Dietary Supplement: Olive oilThese women received 4 1-g capsules with olive oil per day from gestational week 30 until delivery |
| No oil supplement | No intervention | –These women received no capsules with oil |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy pregnant women in gestation week 30
Key exclusion criteria (1 listed)
- Bleeding episodes during pregnancy
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 |
|---|---|---|
| Fish oilAlso: Pikasol4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids | Dietary supplement | Fish oil supplementation |
| Olive oil4 1-g gelatine capsules with virgin olive oil | Dietary supplement | Olive oil |
Primary outcome
Gestation length
Time frame: 1989-1990 (1 year)
We assesed impact of fish oil supplementation in pregnancy on timing of spontaneous delivery
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 28 Feb 2014.
- Results publication: PubMed 1349049Olsen SF, Sorensen JD, Secher NJ, Hedegaard M, Henriksen TB, Hansen HS, Grant A. Randomised controlled trial of effect of fish-oil supplementation on pregnancy duration. Lancet. 1992 Apr 25;339(8800):1003-7. doi: 10.1016/0140-6736(92)90533-9.
- Results publication: PubMed 18614738Olsen SF, Osterdal ML, Salvig JD, Mortensen LM, Rytter D, Secher NJ, Henriksen TB. Fish oil intake compared with olive oil intake in late pregnancy and asthma in the offspring: 16 y of registry-based follow-up from a randomized controlled trial. Am J Clin Nutr. 2008 Jul;88(1):167-75. doi: 10.1093/ajcn/88.1.167.
- Results publication: PubMed 21775563Rytter D, Bech BH, Christensen JH, Schmidt EB, Henriksen TB, Olsen SF. Intake of fish oil during pregnancy and adiposity in 19-y-old offspring: follow-up on a randomized controlled trial. Am J Clin Nutr. 2011 Sep;94(3):701-8. doi: 10.3945/ajcn.111.014969. Epub 2011 Jul 20.
- Results publication: PubMed 21874272Rytter D, Schmidt EB, Bech BH, Christensen JH, Henriksen TB, Olsen SF. Fish oil supplementation during late pregnancy does not influence plasma lipids or lipoprotein levels in young adult offspring. Lipids. 2011 Dec;46(12):1091-9. doi: 10.1007/s11745-011-3606-5. Epub 2011 Aug 27.
- Results publication: PubMed 22313729Rytter D, Christensen JH, Bech BH, Schmidt EB, Henriksen TB, Olsen SF. The effect of maternal fish oil supplementation during the last trimester of pregnancy on blood pressure, heart rate and heart rate variability in the 19-year-old offspring. Br J Nutr. 2012 Oct 28;108(8):1475-83. doi: 10.1017/S0007114511006799. Epub 2012 Feb 7.
- Protocol and correspondencesLink 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.
Sjurdur F. Olsen, MD principal investigator
Statens Serum Institut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil and Olive oil in people with Preterm Delivery and Atopy, run by Centre for Fetal Programming, Denmark at 1 site in Denmark.
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 1 inclusion and 1 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 28 Feb 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 Denmark. 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?
Gestation length (time frame: 1989-1990 (1 year)). 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 NCT01353807, which also lists 5 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 28 Feb 2014.