PregnancyPhase 1NCT00620672
N-3 Fatty Acid Requirements for Human Development
A Phase 1 study testing omega 3 fatty acids and vegetable oil in people with Pregnancy, run by University of British Columbia at 1 site in Canada.
Trial summary
Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for humans, and are known to be important to reducing the risk of certain diseases, particularly those related to neural system, cardiovascular system and immune system. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- omega 3 fatty acids and vegetable oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteCanada
- Study dates
- May 2004to May 2016
- Phase
- Phase 1
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 12-16 weeks gestation
- Low risk pregnancy
- Expected to deliver single full term
- No maternal metabolic or infectious disease
- No known fetal complications.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4
About this study
Official title: To Compare Measures of Central Nervous System Maturity of Visual Acuity, Language, Mental and Motor Skill Development in Term Infants Following Maternal Supplementation Wit the n-3 Fatty Acid Docosahexaenoic Acid (DHA) During Gestation.
Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for humans, and are known to be important to reducing the risk of certain diseases, particularly those related to neural system, cardiovascular system and immune system. Among the different n-3 fatty acids, docosahexaenoic acid (DHA) is present in particularly high amounts in the brain and retina, and is accumulated in large amounts in these organs during the last trimester of fetal development and first few months after birth. The n-3 fatty acids are present in the diet as linolenic acid which is found in vegetable and seed oils, and as DHA which is only found in animal tissue fats, with fatty fish being the richest dietary source. Humans are able to convert linolenic acid to DHA, but the conversion is believed to be slow in human and possibly inadequate to support the needs for DHA for the developing brain. Information from our work and those of others has suggested that DHA is important during pregnancy, however specific evidence is lacking to show that the DHA status of pregnant women in low, or that improvement in the DHA status of Canadian women during pregnancy will have benefit to early infant an child development. There is no evidence that infants of vegans and vegetarians, or women who do not eat DHA are at risk for developmental delays. The purpose of this study is to investigate whether a dietary supplement of DHA during pregnancy has any effect on infant birth weight, or indices of infant growth, visual, mental and motor skill development.
Read the detailed description
This is a randomized, blinded prospective study with 2 groups: placebo and group supplemented with DHA. Women are randomized at 16 weeks gestation without knowledge of their dietary fatty acid intake. Only healthy women expecting to deliver a single infant with no known or anticipated maternal or fetal complications are enrolled. Maternal venous blood is collected at 16 and 36 weeks of gestation and used to assess the maternal DHA status and effect of DHA supplementation. Dietary information is collected at 16 and 36 weeks of gestation to determine usual fatty acid intakes. Following delivery, fetal cord blood is collected to assess transfer of DHA from mother to fetus. Breast milk samples are collected from all breast feeding mothers at 1 and 2 months postpartum. The mother -infant pairs are followed for 18 months. Measures include visual acuity, language, motor and mental development, and growth and dietary intakes.
- Conditions
- Pregnancy
- Being tested
- omega 3 fatty acids, vegetable oil
- Keywords
- n-3 supplementation during pregnancy, DHA and pregnancy, infant development, n-3 status and gestation, DHA and visual acuity and cognition during infancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega 3 fatty acidsDietary supplement
The supplements are taken orally with a meal, each day. The amount of the omega 3 fatty acid docosahexaenoic acid is 400 mg/day; taken in two 500 mg capsules each providing 200 mg docosahexaenoic acid. The placebo is two 500 mg capsules soybean/canola oil. Both the supplement and placebo are a total of 1 gm/day (2x500 mg) and about 10 calories per day.
vegetable oilDietary supplement
The supplement is a dietary supplement of vegetable oil as a placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | The dietary supplement is 400 mg/day of the omega 3 fatty acid docosahexaenoic acid . The docosahexaenoic acid is provided in triglycerides from Martek Biosciences, Maryland. The supplement is a blend of soybean and canola oil, blended to resemble the usual fat composition of the diet. Both the supplement and placebo provide a total of about 10 calories per day to the diet. Receives: Dietary Supplement: omega 3 fatty acids |
| 2 | Other | Dietary supplement is vegetable oil, the placebo. Receives: Dietary Supplement: vegetable oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is measuring of infant CNS maturity to 18 months of age
Primary outcome is measuring of infant CNS maturity to 18 months of age
Measured: 18 months
Secondary outcomes (1)
Length of gestation and infant birth weight, infant growth (weight, length and head circumference) at 1,2 6,9,12,14,and 18 months Language development at 14 and 16 months
- Length of gestation and infant birth weight, infant growth (weight, length and head circumference) at 1,2 6,9,12,14,and 18 months
- Diet, blood an dbreast milk fatty acids
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startMay 2004
- Primary completionDec 2011
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Sheila M. Innis, Ph.D, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620672
- Sponsor's protocol ID
- H03-70242
- Other IDs
- CW03-0084
- Status last verified
- May 2016
- First submitted
- 11 Feb 2008
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mulder KA, King DJ, Innis SM. Omega-3 fatty acid deficiency in infants before birth identified using a randomized trial of maternal DHA supplementation in pregnancy. PLoS One. 2014 Jan 10;9(1):e83764. doi: 10.1371/journal.pone.0083764. eCollection 2014.
PubMed 24427279Friesen RW, Innis SM. Linoleic acid is associated with lower long-chain n-6 and n-3 fatty acids in red blood cell lipids of Canadian pregnant women. Am J Clin Nutr. 2010 Jan;91(1):23-31. doi: 10.3945/ajcn.2009.28206. Epub 2009 Nov 18.
PubMed 19923368Friesen RW, Innis SM. Dietary arachidonic acid to EPA and DHA balance is increased among Canadian pregnant women with low fish intake. J Nutr. 2009 Dec;139(12):2344-50. doi: 10.3945/jn.109.112565. Epub 2009 Oct 28.
PubMed 19864401van Dijk CE, Innis SM. Growth-curve standards and the assessment of early excess weight gain in infancy. Pediatrics. 2009 Jan;123(1):102-8. doi: 10.1542/peds.2007-3382.
PubMed 19117867
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Measures of Central Nervous System Maturity of Visual Acuity, Language, Mental and Motor Skill Development in Term Infants Following Maternal Supplementation Wit the n-3 Fatty Acid Docosahexaenoic Acid (DHA) During Gestation.
- ClinicalTrials.gov ID
- NCT00620672
- Acronym / sponsor ID
- H03-70242
- Conditions
- Pregnancy
- Keywords
- n-3 supplementation during pregnancy, DHA and pregnancy, infant development, n-3 status and gestation, DHA and visual acuity and cognition during infancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- May 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Feb 2008 (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.
Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for humans, and are known to be important to reducing the risk of certain diseases, particularly those related to neural system, cardiovascular system and immune system. Among the different n-3 fatty acids, docosahexaenoic acid (DHA) is present in particularly high amounts in the brain and retina, and is accumulated in large amounts in these organs during the last trimester of fetal development and first few months after birth. The n-3 fatty acids are present in the diet as linolenic acid which is found in vegetable and seed oils, and as DHA which is only found in animal tissue fats, with fatty fish being the richest dietary source. Humans are able to convert linolenic acid to DHA, but the conversion is believed to be slow in human and possibly inadequate to support the needs for DHA for the developing brain. Information from our work and those of others has suggested that DHA is important during pregnancy, however specific evidence is lacking to show that the DHA status of pregnant women in low, or that improvement in the DHA status of Canadian women during pregnancy will have benefit to early infant an child development. There is no evidence that infants of vegans and vegetarians, or women who do not eat DHA are at risk for developmental delays. The purpose of this study is to investigate whether a dietary supplement of DHA during pregnancy has any effect on infant birth weight, or indices of infant growth, visual, mental and motor skill development.
Detailed description
This is a randomized, blinded prospective study with 2 groups: placebo and group supplemented with DHA. Women are randomized at 16 weeks gestation without knowledge of their dietary fatty acid intake. Only healthy women expecting to deliver a single infant with no known or anticipated maternal or fetal complications are enrolled. Maternal venous blood is collected at 16 and 36 weeks of gestation and used to assess the maternal DHA status and effect of DHA supplementation. Dietary information is collected at 16 and 36 weeks of gestation to determine usual fatty acid intakes. Following delivery, fetal cord blood is collected to assess transfer of DHA from mother to fetus. Breast milk samples are collected from all breast feeding mothers at 1 and 2 months postpartum. The mother -infant pairs are followed for 18 months. Measures include visual acuity, language, motor and mental development, and growth and dietary intakes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Dietary Supplement: omega 3 fatty acidsThe dietary supplement is 400 mg/day of the omega 3 fatty acid docosahexaenoic acid . The docosahexaenoic acid is provided in triglycerides from Martek Biosciences, Maryland. The supplement is a blend of soybean and canola oil, blended to resemble the usual fat composition of the diet. Both the supplement and placebo provide a total of about 10 calories per day to the diet. |
| 2 | Other | Dietary Supplement: vegetable oilDietary supplement is vegetable oil, the placebo. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 12-16 weeks gestation
- Low risk pregnancy
- Expected to deliver single full term
- No maternal metabolic or infectious disease
- No known fetal complications.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| omega 3 fatty acidsThe supplements are taken orally with a meal, each day. The amount of the omega 3 fatty acid docosahexaenoic acid is 400 mg/day; taken in two 500 mg capsules each providing 200 mg docosahexaenoic acid. The placebo is two 500 mg capsules soybean/canola oil. Both the supplement and placebo are a total of 1 gm/day (2x500 mg) and about 10 calories per day. | Dietary supplement | 1 |
| vegetable oilThe supplement is a dietary supplement of vegetable oil as a placebo | Dietary supplement | 2 |
Primary outcome
Primary outcome is measuring of infant CNS maturity to 18 months of age
Time frame: 18 months
Primary outcome is measuring of infant CNS maturity to 18 months of age
1 secondary outcome
Length of gestation and infant birth weight, infant growth (weight, length and head circumference) at 1,2 6,9,12,14,and 18 months Language development at 14 and 16 months
Time frame: 72 months
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 1 Jun 2016.
- Derived from this study: PubMed 24427279Mulder KA, King DJ, Innis SM. Omega-3 fatty acid deficiency in infants before birth identified using a randomized trial of maternal DHA supplementation in pregnancy. PLoS One. 2014 Jan 10;9(1):e83764. doi: 10.1371/journal.pone.0083764. eCollection 2014.
- Derived from this study: PubMed 19923368Friesen RW, Innis SM. Linoleic acid is associated with lower long-chain n-6 and n-3 fatty acids in red blood cell lipids of Canadian pregnant women. Am J Clin Nutr. 2010 Jan;91(1):23-31. doi: 10.3945/ajcn.2009.28206. Epub 2009 Nov 18.
- Derived from this study: PubMed 19864401Friesen RW, Innis SM. Dietary arachidonic acid to EPA and DHA balance is increased among Canadian pregnant women with low fish intake. J Nutr. 2009 Dec;139(12):2344-50. doi: 10.3945/jn.109.112565. Epub 2009 Oct 28.
- Derived from this study: PubMed 19117867van Dijk CE, Innis SM. Growth-curve standards and the assessment of early excess weight gain in infancy. Pediatrics. 2009 Jan;123(1):102-8. doi: 10.1542/peds.2007-3382.
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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.
Sheila M. Innis, Ph.D principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing omega 3 fatty acids and vegetable oil in people with Pregnancy, run by University of British Columbia at 1 site in Canada.
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 0 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 1 Jun 2016. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Primary outcome is measuring of infant CNS maturity to 18 months of age (time frame: 18 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 NCT00620672, which also lists 4 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 1 Jun 2016.