An interventional study of white maize and a corn oil capsule and orange maize and a corn oil capsule in Vitamin A Deficiency, sponsored by University of California, Davis. Completed at 1 site in Zambia. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-26.
Sponsored by University of California, Davis · Not applicable and Interventional
The purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating Zambian women.
Lactating women were randomly assigned to one of three intervention groups to receive 6d/wk for 3 wk either 1) provitamin A biofortified orange maize and a corn oil capsule, 2) white maize and a vitamin A capsule, or 3) white maize and a corn oil capsule. The 'orange maize' and 'vitamin A' groups received \~600 ug RAE/d as provitamin A biofortified maize or retinyl palmitate, respectively. The 'white maize' group was a negative control group that did not receive any supplemental vitamin A.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 149 is below the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
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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.
white maize and a corn oil capsule
Other: white maize and a corn oil capsule
orange maize and a corn oil capsule
Other: orange maize and a corn oil capsule
white maize and a vitamin A capsule
Other: white maize and a vitamin A capsule
\~ 0 ug RAE/d
\~600 ug RAE/d
Also known as: beta-carotene biofortified maize
600 ug RAE/d
Also known as: retinyl palmitate capsule
Breast milk retinol concentration
Breast milk retinol concentration will be measured before and after 3 wk of consumption of orange maize (6 d/wk)
Time frame: After 3 weeks of intervention
Breastmilk beta-carotene concentration
Breastmilk beta-carotene concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)
Time frame: After 3 wk of intervention
Plasma retinol concentration
Plasma retinol concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)
Time frame: After 3 wk of intervention
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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