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| Name | Class |
|---|---|
| dsm-firmenich Switzerland AG | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corn oil placebo | Placebo Comparator | Micro-encapsulated powder containing 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docosahexaenoic acid (DHA) and arachidonic acid (ARA) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maturation of cognition as assessed by the Bayley Scales of Infant Development at 24 months of age | 12 months intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Maturation of cognition as assessed by the Wechsler Preschool and Primary Scale of Intelligence at 36 months of age | After 24 months of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eileen E Birch, PhD | Retina Foundation of the Southwest | Principal Investigator |
| Dennis R Hoffman, PhD | Retina Foundation of the Southwest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
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| Label | URL |
|---|---|
| webpage for Retina Foundation of the Southwest | View source |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D016718 | Arachidonic Acid |
| D015525 | Fatty Acids, Omega-3 |
| D043371 | Fatty Acids, Omega-6 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Corn oil placebo | Dietary Supplement | Micro-encapsulated powder containing corn oil as the placebo. |
|
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D001095 | Arachidonic Acids |
| D015777 | Eicosanoids |
| D005228 | Fatty Acids, Essential |