Infant Brain HealthNCT01123759
Healthful Seafood Consumption for Sensitive Populations
A study testing Feeding low mercury fish in people with Infant Brain Health, run by Purdue University at 2 sites in United States.
Trial summary
Fish can provide pregnant women with omega-3 fatty acids for fetal brain development but some fish contains high levels of mercury which is detrimental to fetal brain development. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant Brain Health
- What is being tested?
- Feeding low mercury fish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Dec 2009
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hair mercury levels equal to or greater than 0.8 ppm
Who cannot join
- Pregnant or planning to become pregnant in the next 3 months
- Nursing
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida A&M University
Tallahassee, Florida, 32307-4100
Purdue University, Department of Foods and Nutrition
West Lafayette, Indiana, 47907-2059
About this study
Official title: Consuming Fish to Reduce Mercury Intake While Optimizing Omega-3 Fatty Acid Status
Fish can provide pregnant women with omega-3 fatty acids for fetal brain development but some fish contains high levels of mercury which is detrimental to fetal brain development. The hypothesis is that women who have previously consumed high mercury fish can reduce the mercury level in their bodies and improve their omega-3 levels in three months by eating fish that is high in omega-3 fatty acids and low in mercury.
Read the detailed description
Exposure to methylmercury, a developmental toxicant found primarily in fish. Fish is nutritionally important for providing long chain omega-3 fatty acids that are important for perinatal health. Since maternal transfer of mercury and omega-3 fatty acids are the primary routes for fetal (placental transfer) or infant (maternal milk) exposure, there is a critical need to develop specific advice for childbearing-aged women based upon the 2004 Dietary Guidelines Advisory Committee's recommended intake i.e., consume 8 ounces of fish per week. This clinical trial investigates whether weekly consumption of selected fish species for 12 weeks can improve plasma concentrations of the omega-3 fatty acids (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) while reducing hair or blood mercury concentrations.
- Conditions
- Infant Brain Health
- Being tested
- Feeding low mercury fish
- Keywords
- Fish, mercury, omega-3 fatty acids, infant, brain development, pregnancy, nursing mother, dietary recommendations, Hair mercury, Blood mercury, Recommendations for pregnant or nursing women, Infant brain health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding low mercury fishOther
Subjects fed 6 oz of either tilapia (low omega-3 fish) or salmon (high omega-3 fish) for 3 months. Both fish are low in mercury
| Study group | Role | What they receive |
|---|---|---|
| Tilapia | Active comparator | Subjects are fed 6 oz tilapia once a week for 3 months Receives: Other: Feeding low mercury fish |
| Salmon | Active comparator | Subjects fed 6 oz salmon once a week for 3 months Receives: Other: Feeding low mercury fish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Mercury
The hair mercury after feeding low mercury fish for 3 months
Measured: 3 months
Secondary outcomes (2)
Blood mercury concentration
The blood mercury concentration after feeding low mercury fish for 3 months
Measured: 3 months
Blood omega-3 fatty acid concentrations
Blood omega-3 fatty acid concentration after feeding either salmon or tilapia for 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Brain HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Florida A&M University
- Investigators
- Charles Santerre, Ph.D, Principal investigator, Purdue University, Department of Foods and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123759
- Sponsor's protocol ID
- USDA-CSREES 07-5110-03804
- Status last verified
- May 2010
- First submitted
- 12 May 2010
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consuming Fish to Reduce Mercury Intake While Optimizing Omega-3 Fatty Acid Status
- ClinicalTrials.gov ID
- NCT01123759
- Acronym / sponsor ID
- USDA-CSREES 07-5110-03804
- Conditions
- Infant Brain Health
- Keywords
- Fish, mercury, omega-3 fatty acids, infant, brain development, pregnancy, nursing mother, dietary recommendations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Florida A&M University
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 May 2010 (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.
Fish can provide pregnant women with omega-3 fatty acids for fetal brain development but some fish contains high levels of mercury which is detrimental to fetal brain development. The hypothesis is that women who have previously consumed high mercury fish can reduce the mercury level in their bodies and improve their omega-3 levels in three months by eating fish that is high in omega-3 fatty acids and low in mercury.
Detailed description
Exposure to methylmercury, a developmental toxicant found primarily in fish. Fish is nutritionally important for providing long chain omega-3 fatty acids that are important for perinatal health. Since maternal transfer of mercury and omega-3 fatty acids are the primary routes for fetal (placental transfer) or infant (maternal milk) exposure, there is a critical need to develop specific advice for childbearing-aged women based upon the 2004 Dietary Guidelines Advisory Committee's recommended intake i.e., consume 8 ounces of fish per week. This clinical trial investigates whether weekly consumption of selected fish species for 12 weeks can improve plasma concentrations of the omega-3 fatty acids (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) while reducing hair or blood mercury concentrations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tilapia | Active comparator | Other: Feeding low mercury fishSubjects are fed 6 oz tilapia once a week for 3 months |
| Salmon | Active comparator | Other: Feeding low mercury fishSubjects fed 6 oz salmon once a week for 3 months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Hair mercury levels equal to or greater than 0.8 ppm
Key exclusion criteria (2 listed)
- Pregnant or planning to become pregnant in the next 3 months
- Nursing
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 |
|---|---|---|
| Feeding low mercury fishSubjects fed 6 oz of either tilapia (low omega-3 fish) or salmon (high omega-3 fish) for 3 months. Both fish are low in mercury | Other | Salmon, Tilapia |
Primary outcome
Hair Mercury
Time frame: 3 months
The hair mercury after feeding low mercury fish for 3 months
2 secondary outcomes
Blood mercury concentration
Time frame: 3 months
Blood omega-3 fatty acid concentrations
Time frame: 3 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 14 May 2010.
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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.
Charles Santerre, Ph.D principal investigator
Purdue University, Department of Foods and Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding low mercury fish in people with Infant Brain Health, run by Purdue 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 1 inclusion and 2 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 14 May 2010. 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. 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?
Hair Mercury (time frame: 3 months). 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 14 May 2010.