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A study to evaluate the growth and development of term infants fed either a marketed cow's milk formula, or an experimental cow's milk formula with prebiotics + a different calcium source + a different level of fatty acids and fat, or an experimental cow's milk formula with prebiotic + a different calcium source + a different level of fatty acids and fat
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Marketed cow's milk-based formula |
|
| 2 | Experimental | Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source |
|
| 3 | Experimental | Cow's milk based formula with prebiotic, different level of fatty acids and fat and a different calcium source |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula | Other | Marketed cow's milk base infant formula 20 kcal/oz |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of weight gain | 106 days |
| Measure | Description | Time Frame |
|---|---|---|
| length and head circumference | 106 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol L Berseth, MD | Mead Johnson & Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Pediatric Group | Birmingham | Alabama | 35205 | United States | ||
| Alabama Clinical Therapeutics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22676715 | Derived | Ashley C, Johnston WH, Harris CL, Stolz SI, Wampler JL, Berseth CL. Growth and tolerance of infants fed formula supplemented with polydextrose (PDX) and/or galactooligosaccharides (GOS): double-blind, randomized, controlled trial. Nutr J. 2012 Jun 7;11:38. doi: 10.1186/1475-2891-11-38. |
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| Infant formula | Other | cow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source |
|
|
| Cow's milk infant formula | Other | Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source |
|
|
| Dothan |
| Alabama |
| 36305 |
| United States |
| Central Arkansas Pediatric Clinic | Benton | Arkansas | 72019 | United States |
| Medical Associates | Fayetteville | Arkansas | 72703 | United States |
| Arkansas Children's Hospital Research Institute | Little Rock | Arkansas | 72202 | United States |
| Arkansas Pediatric Clinic | Little Rock | Arkansas | 72205 | United States |
| Norwich Pediatric Group, PC | Norwich | Connecticut | 06360 | United States |
| Palm Beach Clinical Investigation, LLC | West Palm Beach | Florida | 33407 | United States |
| Welborn Clinic Research | Newburgh | Indiana | 47630 | United States |
| Woburn Pediatric Associates Research Department | Woburn | Massachusetts | 01801 | United States |
| Southwestern Medical Clinic, PC | Niles | Michigan | 49120 | United States |
| Southwestern Medical Clinic, PC | Stevensville | Michigan | 49127 | United States |
| Aspen Medical Group | Saint Paul | Minnesota | 55108 | United States |
| The Center for Human Nutrition | Omaha | Nebraska | 68105 | United States |
| Odyssey Research | Minot | North Dakota | 58701 | United States |
| Red Lion Pediatrics | Philadelphia | Pennsylvania | 19114 | United States |
| Primary Physicians Research, Inc | Pittsburgh | Pennsylvania | 15241 | United States |
| Holston Medical Group, MeadowView Lane | Kingsport | Tennessee | 37660 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | United States |
| ID | Term |
|---|---|
| D041943 | Infant Formula |
| D007501 | Iron |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D005526 | Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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