Infant DevelopmentNCT00982462
Effect of Long-Chain Polyunsaturated Fatty Acid Supplementation on Toddler Cognition
A study testing Docosahexaenoic acid (DHA) and arachidonic acid (ARA) in people with Infant Development, run by Retina Foundation of the Southwest at 1 site in United States.
Trial summary
The hypothesis to be examined is that dietary LCP-supplementation in the second and third years of life will improve cognitive and visual maturation in early childhood. Read more about this study
- Who is it for?
- Ages 351 to 379 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Docosahexaenoic acid (DHA) and arachidonic acid (ARA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2011to 29 Jun 2016
- 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 351 to 379 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Toddlers (12 months ± 2 weeks of age at randomization).
- Breast-fed or formula-fed during the first 12 months of life.
- Mother plans to discontinue breast-feeding/formula feeding by 13 months of age.
- Full-term at birth (37-42 weeks post-conception).
- English as the primary language in the home.
Who cannot join
- History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development of the participant or the evaluation of the participant.
- Toddler weighing <5% or >95% of the normative values in Centers for Disease Control and Prevention (CDC) growth charts released in 2000 (www.cdc.gov/growthcharts/).
- Evidence of poor food intake at time of randomization.
- Parent(s) currently supplement or plan to supplement child with >100 mg DHA per day (fish, fish oil, capsules or chewables).
Trial locations and contacts
1 site in 1 country.
United States1 site
Retina Foundation of the Southwest
Dallas, Texas, 75231
About this study
Official title: The Effects of Extended Duration of Long-Chain Polyunsaturated Fatty Acid (LCP)-Supplementation on Neurological and Immunological Development in Toddlers
The hypothesis to be examined is that dietary LCP-supplementation in the second and third years of life will improve cognitive and visual maturation in early childhood.
Read the detailed description
A total number of 114 toddlers at 12 months ± 2 weeks of age will be recruited and randomized to two groups (placebo or LCP-supplemented). Cognition, visual function, anthropometric, immunologic and biochemical status, and health will be assessed upon entry to evaluate equality between study groups.
The primary outcome measure for Part A will be maturation of cognition at 24 months ± 2 weeks of age (after 12 months of LCP dietary intervention) as assessed by the Bayley Scales of Infant Development (BSID)-version III. In Part B, maturation of cognition at 36 months of age (after 24 months of LCP dietary intervention) will be assessed using the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III).
The study supplements are (1) a micro-encapsulated powder containing a 1:1 ratio of the omega-3 fatty acid, docosahexaenoic acid (DHA) and the omega-6 fatty acid, arachidonic acid (ARA) from algal and fungal sources, respectively; and (2) a micro-encapsulated powder containing corn oil placebo. Two foil-packets containing either active intervention or placebo will provide 200mg DHA and 200mg ARA or 400 mg placebo oil per day to the toddler. Two packets of the powders will be added each day to a selection of recommended foods (e.g., yogurt). The duration of treatment will be from 12 to 24 months of age in Part A and in Part B will be from 24 to 36 months and followed to 42 months of age.
Secondary outcome measures are:
- COGNITION: Peabody Picture Vocabulary Test (PPVT-II; 42 mo) and the Bracken Basic Concept Scale (42 mo).
- VISION: Grating \& stereoacuity (12, 24 \& 36 mo); letter acuity at 36 mo.
- ANTHROPOMETRICS, HEALTH INDICES \& DIETARY STATUS: Weight, height, head circumference, waist \& hip measures, body mass index (BMI), skin fold fat deposition, heart rate (HR), blood pressure (BP), omega-3-targeted food questionnaire (at 12,18, 24, 30, 36, \& 42 mo), childhood illnesses from birth to 36 months with emphasis on allergy and asthma chart review and a questionnaire to determine family history of asthma and allergy as well as the child's exposure to smoking (12, 24 \& 36 mo).
- EXECUTIVE FUNCTION: Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P questionnaire; 24 \& 36 mo), Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP; 42 mo), Dimensional Change Card Sort (DCCS; 42 mo), three Stroop Tasks (42 mo), the Grass/Snow task (42 months), and the Day/Night Task (42 months).
- SLEEP: Brief Infant Sleep Questionnaire (BSIQ;12 \& 24 mo), Children's Sleep Habits Questionnaire (CSHQ; 36 \& 42 mo).
- IMMUNE FUNCTION: plasma cytokine levels (12 \& 24 mo), skin prick tests for specific IgEs (12 \& 24 mo), plasma total IgE, salivary (secretory) IgA (12 \& 24 mo), plasma C-reactive protein (CRP;12 \& 24 mo).
- INDICES OF NEURAL TISSUE COMPOSITION AND COMPLIANCE: Total RBC fatty acid analysis (12 \& 24 mo), buccal cheek cell phospholipids fatty acid analysis (12, 24, \& 36 mo).
- Conditions
- Infant Development
- Being tested
- Docosahexaenoic acid (DHA) and arachidonic acid (ARA), Corn oil placebo
- Keywords
- cognition, vision, immunology, DHA, ARA, infant, nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic acid (DHA) and arachidonic acid (ARA)Dietary supplement
Also called Long-chain polyunsaturated fatty acids, omega-3 fatty acids, omega-6 fatty acids
Micro-encapsulated powder containing the long-chain polyunsaturated fatty acids, DHA to ARA in a 1:1 ratio. Two foil-packets containing active intervention (200mg DHA+200mg ARA) or placebo (400 mg corn oil) per day added to a selection of recommended foods.
Corn oil placeboDietary supplement
Also called Long-chain polyunsaturated fatty acids, Omega-6 fatty acids
Micro-encapsulated powder containing corn oil as the placebo.
| Study group | Role | What they receive |
|---|---|---|
| Corn oil placebo | Placebo comparator | Micro-encapsulated powder containing corn oil placebo. Receives: Dietary Supplement: Corn oil placebo |
| Long-chain polyunsaturated fatty acids | Experimental | Micro-encapsulated powder containing 1:1 ratio of the omega-3 long-chain polyunsaturated fatty acids, docosahexaenoic acid (DHA) and the omega-6 fatty acid, arachidonic acid (ARA) from algal and fungal sources, respectively. Receives: Dietary Supplement: Docosahexaenoic acid (DHA) and arachidonic acid (ARA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maturation of cognition as assessed by the Bayley Scales of Infant Development at 24 months of age
Measured: 12 months intervention
Secondary outcomes (1)
Maturation of cognition as assessed by the Wechsler Preschool and Primary Scale of Intelligence at 36 months of age
Measured: After 24 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study start20 Jan 2011
- Primary completion29 Jun 2016
- Study completion29 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Foundation of the Southwest
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Dennis Hoffman, Retina Foundation of the Southwest
- Investigators
- Eileen E Birch, PhD, Principal investigator, Retina Foundation of the SouthwestDennis R Hoffman, PhD, Principal investigator, Retina Foundation of the Southwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982462
- Sponsor's protocol ID
- DSM #2009-1024
- Status last verified
- Apr 2017
- First submitted
- 21 Sep 2009
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Extended Duration of Long-Chain Polyunsaturated Fatty Acid (LCP)-Supplementation on Neurological and Immunological Development in Toddlers
- ClinicalTrials.gov ID
- NCT00982462
- Acronym / sponsor ID
- DSM #2009-1024
- Conditions
- Infant Development
- Keywords
- cognition, vision, immunology, DHA, ARA, infant, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Retina Foundation of the SouthwestUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- 20 Jan 2011 (actual)
- Primary completion
- 29 Jun 2016 (actual)
- Study completion
- 29 Jun 2016 (actual)
- First posted
- 23 Sep 2009 (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 hypothesis to be examined is that dietary LCP-supplementation in the second and third years of life will improve cognitive and visual maturation in early childhood.
Detailed description
A total number of 114 toddlers at 12 months ± 2 weeks of age will be recruited and randomized to two groups (placebo or LCP-supplemented). Cognition, visual function, anthropometric, immunologic and biochemical status, and health will be assessed upon entry to evaluate equality between study groups.
The primary outcome measure for Part A will be maturation of cognition at 24 months ± 2 weeks of age (after 12 months of LCP dietary intervention) as assessed by the Bayley Scales of Infant Development (BSID)-version III. In Part B, maturation of cognition at 36 months of age (after 24 months of LCP dietary intervention) will be assessed using the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III).
The study supplements are (1) a micro-encapsulated powder containing a 1:1 ratio of the omega-3 fatty acid, docosahexaenoic acid (DHA) and the omega-6 fatty acid, arachidonic acid (ARA) from algal and fungal sources, respectively; and (2) a micro-encapsulated powder containing corn oil placebo. Two foil-packets containing either active intervention or placebo will provide 200mg DHA and 200mg ARA or 400 mg placebo oil per day to the toddler. Two packets of the powders will be added each day to a selection of recommended foods (e.g., yogurt). The duration of treatment will be from 12 to 24 months of age in Part A and in Part B will be from 24 to 36 months and followed to 42 months of age.
Secondary outcome measures are:
- COGNITION: Peabody Picture Vocabulary Test (PPVT-II; 42 mo) and the Bracken Basic Concept Scale (42 mo).
- VISION: Grating \& stereoacuity (12, 24 \& 36 mo); letter acuity at 36 mo.
- ANTHROPOMETRICS, HEALTH INDICES \& DIETARY STATUS: Weight, height, head circumference, waist \& hip measures, body mass index (BMI), skin fold fat deposition, heart rate (HR), blood pressure (BP), omega-3-targeted food questionnaire (at 12,18, 24, 30, 36, \& 42 mo), childhood illnesses from birth to 36 months with emphasis on allergy and asthma chart review and a questionnaire to determine family history of asthma and allergy as well as the child's exposure to smoking (12, 24 \& 36 mo).
- EXECUTIVE FUNCTION: Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P questionnaire; 24 \& 36 mo), Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP; 42 mo), Dimensional Change Card Sort (DCCS; 42 mo), three Stroop Tasks (42 mo), the Grass/Snow task (42 months), and the Day/Night Task (42 months).
- SLEEP: Brief Infant Sleep Questionnaire (BSIQ;12 \& 24 mo), Children's Sleep Habits Questionnaire (CSHQ; 36 \& 42 mo).
- IMMUNE FUNCTION: plasma cytokine levels (12 \& 24 mo), skin prick tests for specific IgEs (12 \& 24 mo), plasma total IgE, salivary (secretory) IgA (12 \& 24 mo), plasma C-reactive protein (CRP;12 \& 24 mo).
- INDICES OF NEURAL TISSUE COMPOSITION AND COMPLIANCE: Total RBC fatty acid analysis (12 \& 24 mo), buccal cheek cell phospholipids fatty acid analysis (12, 24, \& 36 mo).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corn oil placebo | Placebo comparator | Dietary Supplement: Corn oil placeboMicro-encapsulated powder containing corn oil placebo. |
| Long-chain polyunsaturated fatty acids | Experimental | Dietary Supplement: Docosahexaenoic acid (DHA) and arachidonic acid (ARA)Micro-encapsulated powder containing 1:1 ratio of the omega-3 long-chain polyunsaturated fatty acids, docosahexaenoic acid (DHA) and the omega-6 fatty acid, arachidonic acid (ARA) from algal and fungal sources, respectively. |
Who may qualify
- Ages
- 351 to 379 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Toddlers (12 months ± 2 weeks of age at randomization).
- Breast-fed or formula-fed during the first 12 months of life.
- Mother plans to discontinue breast-feeding/formula feeding by 13 months of age.
- Full-term at birth (37-42 weeks post-conception).
- English as the primary language in the home.
Key exclusion criteria (4 listed)
- History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development of the participant or the evaluation of the participant.
- Toddler weighing <5% or >95% of the normative values in Centers for Disease Control and Prevention (CDC) growth charts released in 2000 (www.cdc.gov/growthcharts/).
- Evidence of poor food intake at time of randomization.
- Parent(s) currently supplement or plan to supplement child with >100 mg DHA per day (fish, fish oil, capsules or chewables).
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 |
|---|---|---|
| Docosahexaenoic acid (DHA) and arachidonic acid (ARA)Also: Long-chain polyunsaturated fatty acids, omega-3 fatty acids, omega-6 fatty acidsMicro-encapsulated powder containing the long-chain polyunsaturated fatty acids, DHA to ARA in a 1:1 ratio. Two foil-packets containing active intervention (200mg DHA+200mg ARA) or placebo (400 mg corn oil) per day added to a selection of recommended foods. | Dietary supplement | Long-chain polyunsaturated fatty acids |
| Corn oil placeboAlso: Long-chain polyunsaturated fatty acids, Omega-6 fatty acidsMicro-encapsulated powder containing corn oil as the placebo. | Dietary supplement | Corn oil placebo |
Primary outcome
Maturation of cognition as assessed by the Bayley Scales of Infant Development at 24 months of age
Time frame: 12 months intervention
1 secondary outcome
Maturation of cognition as assessed by the Wechsler Preschool and Primary Scale of Intelligence at 36 months of age
Time frame: After 24 months of intervention
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 25 Apr 2017.
- webpage for Retina Foundation of the SouthwestLink 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.
Eileen E Birch, PhD principal investigator
Retina Foundation of the Southwest
Dennis R Hoffman, PhD principal investigator
Retina Foundation of the Southwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docosahexaenoic acid (DHA) and arachidonic acid (ARA) in people with Infant Development, run by Retina Foundation of the Southwest at 1 site 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 5 inclusion and 4 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 25 Apr 2017. 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 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?
Maturation of cognition as assessed by the Bayley Scales of Infant Development at 24 months of age (time frame: 12 months intervention). 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 25 Apr 2017.