Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status
NCT ID: NCT01420406
Last Updated: 2012-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2010-06-30
2012-06-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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0 mg retinol
0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
0 mg retinol activity equivalents
0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
12 mg BC
12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule.
12 mg of BC
12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule
6 mg of CX
6 mg of CX as tangerines and a corn oil capsule
6 mg of CX
6 mg of CX as tangerines and a corn oil capsule
1.0 mg RAE
1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes
1.0 mg RAE
1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes
Interventions
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0 mg retinol activity equivalents
0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
12 mg of BC
12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule
6 mg of CX
6 mg of CX as tangerines and a corn oil capsule
1.0 mg RAE
1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of California, Davis
OTHER
USDA, Western Human Nutrition Research Center
FED
Responsible Party
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Principal Investigators
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Betty J Burri, PhD
Role: PRINCIPAL_INVESTIGATOR
WHNRC
Locations
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International Centre for Diarrhoeal Disease Research
Dhaka, , Bangladesh
Countries
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References
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Turner T, Burri BJ, Jamil KM, Jamil M. The effects of daily consumption of beta-cryptoxanthin-rich tangerines and beta-carotene-rich sweet potatoes on vitamin A and carotenoid concentrations in plasma and breast milk of Bangladeshi women with low vitamin A status in a randomized controlled trial. Am J Clin Nutr. 2013 Nov;98(5):1200-8. doi: 10.3945/ajcn.113.058180. Epub 2013 Sep 4.
Other Identifiers
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WHNRC 200816672
Identifier Type: -
Identifier Source: org_study_id