Status:
COMPLETED
Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status
Lead Sponsor:
USDA, Western Human Nutrition Research Center
Collaborating Sponsors:
University of California, Davis
Conditions:
Vitamin A Deficiency
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 la...
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 cryptoxa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01420406
Start Date
June 1 2010
End Date
June 1 2012
Last Update
September 12 2012
Active Locations (1)
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1
International Centre for Diarrhoeal Disease Research
Dhaka, Bangladesh