Clinical Trials Directory

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

TypeNameDescription
OTHER0 mg retinol activity equivalents0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
OTHER12 mg of BC12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule
OTHER6 mg of CX6 mg of CX as tangerines and a corn oil capsule
OTHER1.0 mg RAE1.0 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.