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| Name | Class |
|---|---|
| SynteractHCR | INDUSTRY |
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The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6 months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates, immune markers) and safety information in these 12-18 month old infants.
This study is a randomized, double-blind, parallel-group study of 0% ARA +0.4% DHA or 0.76% ARA +0.4% DHA supplemented infant formula provided to 6 months old healthy infants for 6 months. Infants will have been breast-fed or formula-fed prior to enrollment. The difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation will be measured. Parents will be asked about the infant's current daily diet (fatty acid intakes calculated via 24 hour recalls). All completed infants will be enrolled into a 6 month extension period (non-supplemented) to collect additional measures of efficacy (i.e. infections and illnesses, immune markers) and safety out to 18 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination ARA+ DHA | Active Comparator | combination 0.76% ARA+ 0.4% DHA in infant formula per day |
|
| DHA | Experimental | 0% ARA +0.4% DHA in infant formula per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combination ARA + DHA | Dietary Supplement | combination ARA + DHA supplemented infant formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| total plasma fatty acid ARA levels | difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation | 6 months of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of infections | record number, type and duration of infections | 6 months of supplementation |
| weight gain | differences between groups in weight gain (kg/d) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ascension Marcos, PhD | Instituto de Ciencia y TecnologÃa de Alimentos y Nutrición | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud Aravaca | Madrid | Spain | ||||
| Centro Salud Arganda del Rey |
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| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| DHA | Dietary Supplement | DHA supplemented infant formula |
|
|
| 6 months of supplementation |
| length gain | differences between groups in length gain (cm/d) | 6 months of supplementation |
| head circumference | differences between groups in head circumference (cm/d) | 6 months of supplementation |
| dietary intake of ARA | 24 hour recall questionnaire | 6 months of supplementation |
| plasma levels of immune markers | cytokines and T cells levels in plasma will be measured | 6 months of supplementation |
| Madrid |
| Spain |
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |