A Phase 3 interventional study of Conventional white maize and Provitamin A carotenoid biofortified maize in Vitamin A Deficiency, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Zambia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-21.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 3, Interventional, and Prevention
The purpose of this randomized control trial is to test the impact of provitamin A carotenoid biofortified maize meal consumption on maternal and infant vitamin A status.
Vitamin A deficiency remains a major public health problem in low and middle income countries. Approximately 50% of Zambian children are thought to be affected. This randomized control trial will test the efficacy of provitamin A carotenoid biofortified maize meal consumption as a strategy to improve vitamin A status among lactating Zambian mothers and their infants. The investigators will enroll up to 255 mother/infant pairs to a three-month study, during which they will receive one of the following three interventions: 1) conventional white maize, 2) provitamin A carotenoid biofortified orange maize, or 3) preformed vitamin A fortified white maize.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 255 is above the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 41 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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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.
Conventional maize flour
Dietary Supplement: Conventional white maize
Provitamin A carotenoid biofortified maize flour
Dietary Supplement: Provitamin A carotenoid biofortified maize
Retinyl palmitate fortified maize flour
Dietary Supplement: Preformed vitamin A fortified maize
Women and their infants will receive 2 meals/day prepared with conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
Women and their infants will receive 2 meals/day prepared with provitamin A carotenoid biofortified orange maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
Women and their infants will receive 2 meals/day prepared with preformed vitamin A fortified, conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
Infant vitamin A stores
Total body vitamin A stores of infants measured by retinol isotope dilution
Time frame: 90 days
Maternal breast milk retinol
Breast milk retinol concentrations of women measured by high performance liquid chromatography
Time frame: 90 days
Maternal plasma retinol
Plasma retinol concentrations of women measured by high performance liquid chromatography
Time frame: 90 days
Maternal dark adaptation
Pupillary responsiveness of women measured by portable field dark adaptometer
Time frame: 90 days
The record gives a start of Mar 2016, a primary completion of Jun 2017 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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