HealthyPhase 3NCT00351624
Effects of Docosahexaenoic Acid (DHA) on Cognitive Function in Children 4 Years of Age
A Phase 3 study testing DHA in people with Healthy, run by dsm-firmenich Switzerland AG at 10 sites in United States.
Trial summary
The primary objective of this study is to determine whether a 4-month period of supplementation with 400 mg/day of docosahexaenoic acid (DHA) provided from chewable softgel capsules containing bubblegum flavored microalgal oil (DHASCO-S) versus placebo improves one or more cognitive measures of attention, memory… Read more about this study
- Who is it for?
- Ages 4 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DHA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 10 sitesUnited States
- Study dates
- May 2006to Sep 2007
- Phase
- Phase 3
- 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 4 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female, age at enrollment between 4 years 0 months and 4 years 8 months
- Height and weight between the 10th and 90th percentiles of the National Center for Health Statistics (NCHS) growth charts
- Subject must meet normal developmental milestones.
- Subject able to understand instructions provided during the cognitive testing, i.e. English must be the primary language in the home
- No evidence of a medical condition that would preclude successful response or outcome (e.g., uncorrected vision or hearing impairment, attention deficit disorder, or inborn error of metabolism)
- Not taking any medications for seizure disorder, anxiety disorders (e.g., Valium or related compounds), ADHD (e.g., Ritalin, Adderall, Concerta, Strattera, or similar medication), childhood psychosis (e.g., Haldol, Risperdal), depression (e.g., Prozac), or for bipolar disorder. A subject will not be withdrawn from the trial if he/she needs to take one of these medications after enrollment. Antihistamines (e.g., Benadryl or other antihistamines) should not be administered within 24 hours of the day of the cognitive exams (Claritin or Allegra are allowed). If a subject is taking an antihistamine on the day of the cognitive tests, the tests will be rescheduled.
Who cannot join
- Premature birth (< 36 weeks gestation)
- Family history of ADHD
- Subject consumes > 3 oz. of fish more than 2 times per week.
- Subject consumes dietary supplements or foods containing or fortified with omega-3 fatty acids.
- Subject received any investigational product within the past 30 days.
- Subject having any medical condition that in the opinion of the principal investigator would preclude a successful response or outcome (e.g., uncorrected vision or hearing impairment, attention deficit disorder or inborn error of metabolism)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Northern Illinois Research Associates
DeKalb, Illinois, 60135
Prevention and Strengthening Solutions, Inc.
Humboldt, Tennessee, 38343
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Impact Clinical Trials
Los Angeles, California, 90010
Children's Hospital of the King's Daughters/Eastern Virginia Medical School
Norfolk, Virginia, 23510
Eminence Research, LLC
Oklahoma City, Oklahoma, 73118
Pedia Research
Owensboro, Kentucky, 42301
Southwest Children's Research Associates
San Antonio, Texas, 78229
Clinical Research Atlanta
Stockbridge, Georgia, 30281
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in Preschool Children
The primary objective of this study is to determine whether a 4-month period of supplementation with 400 mg/day of docosahexaenoic acid (DHA) provided from chewable softgel capsules containing bubblegum flavored microalgal oil (DHASCO-S) versus placebo improves one or more cognitive measures of attention, memory, processing speed, and error rate in healthy children 4 years of age.
The secondary objectives are to measure the safety and tolerability of the DHA dose administered and to measure blood DHA levels before and after supplementation.
Read the detailed description
DHA is the primary omega-3 fatty acid present in the brain and retina and plays crucial structural and functional roles in these issues. The primary dietary source of DHA is fatty fish (e.g., salmon, herring, tuna). The American diet provides one of the lowest levels of omega-3 fatty acids of most industrialized nations. Children between the ages of 1 and 5 years consume only 30 to 50 mg DHA per day despite high requirements for this nutrient to support growth and tissue turnover.
Studies with human infants have reported visual and cognitive benefits of DHA supplementation in early life. Reported benefits include significant improvements on tests of visual acuity during infancy, psychomotor or mental development in the first two years of life, and problem-solving and sustained attention around 5 years of age.
Few studies have evaluated the effect that DHA supplementation has on the cognitive function of older children. Studies that considered DHA supplementation in children 4-12 years of age with attention-deficit/hyperactivity disorder (ADHD) or other developmental disorders have shown improvements on several measures of attention, behavior, and executive function.
Given the estimated high requirements of DHA to support growth and maintenance of the brain, the low consumption of DHA by American children, and the evidence from human and animal studies that DHA status affects the functional capacity of the central nervous system, there is a reasonable expectation that DHA supplementation administered to preschool-aged children will improve performance on tests of attention, memory, processing speed, and error rate.
- Conditions
- Healthy
- Being tested
- DHA, placebo
- Keywords
- DHA supplementation, Cognitive function, Preschool children, Attention and behavior, Healthy Children
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHABehavioural
placeboBehavioural
| Study group | Role | What they receive |
|---|---|---|
| DHA | Active comparator | Not described Receives: Behavioral: DHA |
| placebo | Placebo comparator | Not described Receives: Behavioral: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leiter Test of Sustained Attention
Kiddie Continuous Performance Test (kCAP)
Peabody Picture Vocabulary Test
Day-Night Stroop Test
Secondary outcomes (2)
Safety and tolerability of the DHA dose
Blood DHA levels before and after DHA supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startMay 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan S Ryan, PhD, Study director, dsm-firmenich Switzerland AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351624
- Sponsor's protocol ID
- Martek #2006-1008
- Status last verified
- May 2014
- First submitted
- 11 Jul 2006
- Last updated
- 20 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in Preschool Children
- ClinicalTrials.gov ID
- NCT00351624
- Acronym / sponsor ID
- Martek #2006-1008
- Conditions
- Healthy
- Keywords
- DHA supplementation, Cognitive function, Preschool children, Attention and behavior, Healthy Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 13 Jul 2006 (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 primary objective of this study is to determine whether a 4-month period of supplementation with 400 mg/day of docosahexaenoic acid (DHA) provided from chewable softgel capsules containing bubblegum flavored microalgal oil (DHASCO-S) versus placebo improves one or more cognitive measures of attention, memory, processing speed, and error rate in healthy children 4 years of age.
The secondary objectives are to measure the safety and tolerability of the DHA dose administered and to measure blood DHA levels before and after supplementation.
Detailed description
DHA is the primary omega-3 fatty acid present in the brain and retina and plays crucial structural and functional roles in these issues. The primary dietary source of DHA is fatty fish (e.g., salmon, herring, tuna). The American diet provides one of the lowest levels of omega-3 fatty acids of most industrialized nations. Children between the ages of 1 and 5 years consume only 30 to 50 mg DHA per day despite high requirements for this nutrient to support growth and tissue turnover.
Studies with human infants have reported visual and cognitive benefits of DHA supplementation in early life. Reported benefits include significant improvements on tests of visual acuity during infancy, psychomotor or mental development in the first two years of life, and problem-solving and sustained attention around 5 years of age.
Few studies have evaluated the effect that DHA supplementation has on the cognitive function of older children. Studies that considered DHA supplementation in children 4-12 years of age with attention-deficit/hyperactivity disorder (ADHD) or other developmental disorders have shown improvements on several measures of attention, behavior, and executive function.
Given the estimated high requirements of DHA to support growth and maintenance of the brain, the low consumption of DHA by American children, and the evidence from human and animal studies that DHA status affects the functional capacity of the central nervous system, there is a reasonable expectation that DHA supplementation administered to preschool-aged children will improve performance on tests of attention, memory, processing speed, and error rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA | Active comparator | Behavioral: DHA |
| placebo | Placebo comparator | Behavioral: placebo |
Who may qualify
- Ages
- 4 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female, age at enrollment between 4 years 0 months and 4 years 8 months
- Height and weight between the 10th and 90th percentiles of the National Center for Health Statistics (NCHS) growth charts
- Subject must meet normal developmental milestones.
- Subject able to understand instructions provided during the cognitive testing, i.e. English must be the primary language in the home
- No evidence of a medical condition that would preclude successful response or outcome (e.g., uncorrected vision or hearing impairment, attention deficit disorder, or inborn error of metabolism)
Key exclusion criteria (6 listed)
- Premature birth (< 36 weeks gestation)
- Family history of ADHD
- Subject consumes > 3 oz. of fish more than 2 times per week.
- Subject consumes dietary supplements or foods containing or fortified with omega-3 fatty acids.
- Subject received any investigational product within the past 30 days.
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 |
|---|---|---|
| DHA | Behavioural | DHA |
| placebo | Behavioural | placebo |
Primary outcome
Leiter Test of Sustained Attention
Kiddie Continuous Performance Test (kCAP)
Peabody Picture Vocabulary Test
Day-Night Stroop Test
2 secondary outcomes
Safety and tolerability of the DHA dose
Blood DHA levels before and after DHA supplementation
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 20 May 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.
Alan S Ryan, PhD study director
dsm-firmenich Switzerland AG
10 sites 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 Healthy, run by dsm-firmenich Switzerland AG at 10 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 6 inclusion and 6 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
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?
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?
Leiter Test of Sustained Attention. The study lists 4 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 20 May 2014.