Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children

Conditions

Low Serum Retinol, Vitamin A Deficiency

Keywords

beta-carotene biofortified maize, micronutrients, vitamin A, serum retinol, dark adaptation

Brief summary

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.

Detailed description

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.

Healy K, Palmer AC, Barffour MA, Schulze KJ, Siamusantu W, Chileshe J, West KP, Labrique AB.

2018-07-017 citations

10.1093/jn/nxy069

Impact of biofortified maize consumption on serum carotenoid concentrations in Zambian children.

Palmer AC, Craft NE, Schulze KJ, Barffour M, Chileshe J, Siamusantu W, West KP.

2018-01-109 citations

10.1038/s41430-017-0054-1

High Iron Stores in the Low Malaria Season Increase Malaria Risk in the High Transmission Season in a Prospective Cohort of Rural Zambian Children.

Barffour MA, Schulze KJ, Coles CL, Chileshe J, Kalungwana N, Arguello M, Siamusantu W, Moss WJ, West KP, Palmer AC.

2017-07-1213 citations

10.3945/jn.117.250381

Provitamin A Carotenoid-Biofortified Maize Consumption Increases Pupillary Responsiveness among Zambian Children in a Randomized Controlled Trial.

Palmer AC, Healy K, Barffour MA, Siamusantu W, Chileshe J, Schulze KJ, West KP, Labrique AB.

2016-10-1930 citations

10.3945/jn.116.239202

Provitamin A-biofortified maize increases serum β-carotene, but not retinol, in marginally nourished children: a cluster-randomized trial in rural Zambia.

Palmer AC, Siamusantu W, Chileshe J, Schulze KJ, Barffour M, Craft NE, Molobeka N, Kalungwana N, Arguello MA, Mitra M, Caswell B, Klemm RD, West KP.

2016-05-1144 citations

10.3945/ajcn.116.132571

Interventions

DIETARY_SUPPLEMENTβ-Carotene Biofortified Maize Flour

DIETARY_SUPPLEMENTWhite Maize Flour

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 8 Years

Healthy volunteers

Yes

Inclusion criteria

* Children 4-8 years of age

Design outcomes

Primary

Measure	Time frame	Description
Increased Serum Retinol Concentration	After 6 months of feeding	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.
Decreased Prevalence of Vitamin A deficiency	After 6 months of feeding	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%.

Secondary

Measure	Time frame	Description
Improved Dark Adaptation	After 6 months of Feeding	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.

Countries

Zambia

Outcome results

None listed