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To investigate the impact of nutrient supplementation during lactation on levels in breast milk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Supplement | Placebo Comparator | soft-gel placebo capsules, 2 capsules from the placebo bottle per day |
|
| Experimental Supplement A | Experimental | soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day |
|
| Experimental Supplement B | Experimental | soft-gel capsules; 2 capsules from the experimental bottle per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Similac Prenatal Vitamin soft-gel capsule | Dietary Supplement | One capsule per day for Experimental Supplement A Group; Two capsules per day for Experimental Supplement B Group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast milk concentration of carotenoids | 1 - 43 days |
| Measure | Description | Time Frame |
|---|---|---|
| Breast milk concentration of fatty acids | 1 - 43 days |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of nutrients and fatty acids | In mothers at 1 and 43 days In infants at 43 days | 1 and 43 days |
Inclusion Criteria:
Subjects will be eligible for the study if they meet all of the following inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Sherry, PhD, RD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northpoint Pediatrics, LLC | Indianapolis | Indiana | 46256 | United States | ||
| Ohio Pediatric Research Association, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24899160 | Derived | Sherry CL, Oliver JS, Renzi LM, Marriage BJ. Lutein supplementation increases breast milk and plasma lutein concentrations in lactating women and infant plasma concentrations but does not affect other carotenoids. J Nutr. 2014 Aug;144(8):1256-63. doi: 10.3945/jn.114.192914. Epub 2014 Jun 4. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013024 | Soybean Oil |
| D024502 | alpha-Tocopherol |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo (soybean oil and dl-alpha-tocopheryl acetate) | Dietary Supplement | Two capsules per day for the Placebo Group; One capsule per day for the Experimental Group A |
|
| Dayton |
| Ohio |
| 45414 |
| United States |
| Ohio Pediatric Research Association, Inc | Kettering | Ohio | 45420 | United States |
| Institute of Clinical Research | Mayfield Heights | Ohio | 44124 | United States |
| The Cleveland Pediatric Research Center, LLC | Parma | Ohio | 44129 | United States |
| The Cleveland Pediatric Research Center, LLC | Westlake | Ohio | 44145 | United States |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D024505 | Tocopherols |
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |