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

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 3

Conditions: Vitamin A Deficiency; Low Serum Retinol

Treatments: Dietary Supplement: β-Carotene Biofortified Maize Flour; Dietary Supplement: White Maize Flour

Study type: Interventional

Funder types: Other

Identifiers

NCT01695148

JHU IRB 4150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,228 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Children 4-8 years of age

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,228 participants in 3 patient groups

White Maize Flour

Active Comparator group

Description:

Children will receive 2 meals a day (\~200 g of white maize flour), 6 days a week for 6 months.

Treatment:

Dietary Supplement: White Maize Flour

β-Carotene Biofortified Maize

Experimental group

Description:

Children will receive 2 meals a day (\~200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months.

Treatment:

Dietary Supplement: β-Carotene Biofortified Maize Flour

Non-Intervened

No Intervention group

Description:

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.