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| Name | Class |
|---|---|
| Helen Keller International | OTHER |
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The purpose of this pilot study is to determine whether breast milk retinol concentration increases in response to daily supplementation with small amounts of vitamin A (~600 ug RAE/d), as either a b-carotene or retinyl palmitate, 6 d/week for 3 weeks. A secondary purpose is to evaluate sampling methods for collecting breast milk samples in a community setting. The results of this pilot study will allow us to determine whether milk retinol is a useful indicator for evaluating the impact of food-based interventions on the vitamin A status of lactating women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| b-carotene | Experimental | 600 ug RAE/d as b-carotene, 6 d/wk for 3 weeks |
|
| retinyl palmitate | Active Comparator | 600 ug retinol equivalent/d, 6 d/wk for 3 weeks |
|
| placebo (corn oil) | Placebo Comparator | 0 ug RAE/d as corn oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| b-carotene | Dietary Supplement |
| ||
| retinyl palmitate |
| Measure | Description | Time Frame |
|---|---|---|
| breast milk retinol concentration | breast milk retinol concentration is measured at baseline and after 3 weeks of supplementation with 600 ug RAE/d (as either b-carotene or retinyl palmitate) or 0 ug RAE/d | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| plasma retinol concentration | plasma retinol concentration is measured at baseline and after 3 weeks of supplementation with 600 ug RAE/d (as either b-carotene or retinyl palmitate) or 0 ug RAE/d | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Davis | California | 95616 | United States |
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| ID | Term |
|---|---|
| D019207 | beta Carotene |
| C014794 | retinol palmitate |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
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|
| placebo | Dietary Supplement |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |