Trials / Completed
CompletedNCT01420406
Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status
Impact of Daily Feeding of Food Sources of Cryptoxanthin (CX) and Beta-carotene (BC) on Plasma and Breast Milk Concentrations of CX, BC, and Retinol (VA) in Lactating Women With Marginal Vitamin A Status
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- USDA, Western Human Nutrition Research Center · Federal
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol concentrations in lactating Bangladeshi women.
Detailed description
The specific aim is to compare the effects of orange-fleshed sweet potatoes and tangerines compared to white-fleshed sweet potatoes and vitamin A as retinyl palmitate on blood and breast milk cryptoxanthin (CX), beta-carotene (BC), and vitamin A (VA) concentrations by randomly assigning lactating Bangladeshi women to one of four treatment groups for 6 days/week for 3 weeks. The investigators will also compare the relative vitamin A (VA) value of BC and CX from food sources by comparing the mean change in breast milk retinol concentrations of the groups that receive tangerines (CX) or orange-fleshed sweet potatoes (BC) with the mean change in breast milk retinol of the group that receives retinyl palmitate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 0 mg retinol activity equivalents | 0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule |
| OTHER | 12 mg of BC | 12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule |
| OTHER | 6 mg of CX | 6 mg of CX as tangerines and a corn oil capsule |
| OTHER | 1.0 mg RAE | 1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2011-05-01
- Completion
- 2012-06-01
- First posted
- 2011-08-19
- Last updated
- 2012-09-12
Locations
1 site across 1 country: Bangladesh
Source: ClinicalTrials.gov record NCT01420406. Inclusion in this directory is not an endorsement.