Vitamin A Deficiency
Conditions
Keywords
lactation, cryptoxanthin, beta-carotene, vitamin A
Brief 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.
Interventions
OTHER0 mg retinol activity equivalents
0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
OTHER12 mg of BC
12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule
OTHER6 mg of CX
6 mg of CX as tangerines and a corn oil capsule
OTHER1.0 mg RAE
1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes
Sponsors
University of California, Davis
USDA, Western Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy women in Dhaka, Bangladesh * Lactating women in their 2nd or 3rd month of lactation who are planning to breast-feed at least 6 months * Breast-feeding only one infant * Age range 18 to 45 years * Not pregnant * Serum retinol concentrations \>0.70 umol/L and \<1.10 umol/L * Normal concentrations of CRP (\<10 mg/L) * At least one arm vein deemed adequate for blood collection, as evaluated by a screening nurse. * Willing to consume the test foods daily 6 d/wk for one month
Exclusion criteria
* Health status is not compatible with the inclusion criteria, such as screening blood chemistries indicative of vitamin A deficiency. * Severe anemia (Hb \<9 mg/dL) * Current pregnancy * Must not have known allergy to citrus fruit (tangerines or mandarin oranges) or sweet potatoes * Must have no obvious psychological or sociological problems-such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an inform consent agreement or to participate in study duties and activities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in carotenoids in serum and breast milk | 1 and 3 weeks | We will measure serum and breast milk beta-carotene, beta-cryptoxanthin, other carotenoids, and vitamins A and E. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dark adaptation | 1 and 3 weeks | Dark adaptation will be measured by the pupillary threshold (PT) test on the first and 3rd weeks of the study. |
Countries
Bangladesh
Outcome results
None listed