An interventional study of 0 mg retinol activity equivalents and 12 mg of BC in Vitamin A Deficiency, sponsored by USDA, Western Human Nutrition Research Center. Completed at 1 site in Bangladesh. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-12.
Sponsored by USDA, Western Human Nutrition Research Center · Not applicable, Interventional, and Basic science
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.
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.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 140 is below the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →USDA, Western Human Nutrition Research Center is the lead sponsor of 54 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
Other: 0 mg retinol activity equivalents
12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule.
Other: 12 mg of BC
6 mg of CX as tangerines and a corn oil capsule
Other: 6 mg of CX
1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes
Other: 1.0 mg RAE
0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule
6 mg of CX as tangerines and a corn oil capsule
1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes
Change in carotenoids in serum and breast milk
We will measure serum and breast milk beta-carotene, beta-cryptoxanthin, other carotenoids, and vitamins A and E.
Time frame: 1 and 3 weeks
Change in Dark adaptation
Dark adaptation will be measured by the pupillary threshold (PT) test on the first and 3rd weeks of the study.
Time frame: 1 and 3 weeks
The record gives a start of Jun 2010, a primary completion of May 2011 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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USDA, Western Human Nutrition Research Center