A Phase 3 interventional study of β-Carotene Biofortified Maize Flour and White Maize Flour in Vitamin A Deficiency and Low Serum Retinol, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Zambia. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-07.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 3, Interventional, and Prevention
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
The purpose of this cluster-randomized trial is to examine whether daily consumption of β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and improve the vitamin A status and among 4-8 year old children in rural Zambia.
Vitamin A deficiency is a major public health problem in Zambia, affecting approximately 40% of young children. We aim to conduct a cluster-randomised controlled trial in the Mkushi region of rural Zambia to test whether feeding children two daily meals containing β-carotene biofortified maize flour compared to regular white maize flour-based meals for six months can reduce the prevalence of vitamin A deficiency and improve the vitamin A status among 4-8 year old children. Five hundred children in each arm will receive 2 meals a day, 6 days a week for 6 months, after which changes in serum retinol concentrations will be compared. An additional arm of 250 children, enrolled from randomly sampled clusters, will not receive the maize flour intervention but concurrently followed in order to evaluate overall effects of the maize flour feeding scheme on measures of household food security.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 1,228 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.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Children will receive 2 meals a day (\~200 g of white maize flour), 6 days a week for 6 months.
Dietary Supplement: White Maize Flour
Children will receive 2 meals a day (\~200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months.
Dietary Supplement: β-Carotene Biofortified Maize Flour
Children will receive no food for the duration of the study, but families in this group will receive an equivalent ration of food items at the end of the trial.
Increased Serum Retinol Concentration
The investigators hypothesize a difference of 2.5 μg/dL or more in serum retinol among children receiving biofortified versus white maize flour-based meals. Serum retinol measures will be collected at baseline and at the end of 6 months and assessed by a High Performance Liquid Chromatography assay.
Time frame: After 6 months of feeding
Decreased Prevalence of Vitamin A deficiency
The investigators hypothesize a difference of 10% or more in the prevalence of vitamin A deficiency (i.e., serum retinol \< 0.7 μmol/l) among children consuming biofortified versus white maize flour-based meals, assuming a baseline prevalence of 40%.
Time frame: After 6 months of feeding
Improved Dark Adaptation
The investigators hypothesize a difference in pupillary response to a light stimulus, as detected by dark adaptometry, in children receiving biofortified versus white maize flour-based meals.
Time frame: After 6 months of Feeding
The record gives a start of Aug 2012, a primary completion of Mar 2013 and a completion of Jun 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johns Hopkins Bloomberg School of Public Health →