Vitamin A Deficiency Clinical Trial
Official title:
The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
The study comprises an open-label randomized controlled trial investigating the efficacy of consuming a daily ration of pro-vitamin A biofortified cassava on vitamin A status of Nigerian children, aged 3-4 years old (n=200).
Objective: The primary objective is to assess the efficacy of daily consumption of
pro-vitamin A rich cassava during 10 weeks on body retinol pools of 3-4 year old children in
Nigeria after high-dose vitamin A supplementation. The secondary objectives are: 1) To
investigate the effect of daily consumption of pro-vitamin A rich cassava on functional
indicators such as nutritional anaemia and gut integrity; 2) To investigate the effect of
zinc deficiency and genetic polymorphisms in the Beta-Carotene Oxygenase 1 (BCO1) and related
genes on the efficacy of pro-vitamin A rich cassava consumption; 3) To compare the skin
colour in the palm of the hand of each participant with their serum retinol levels using a
handheld non-invasive spectrophotometer.
Study design: Open-label (single-blinded) randomized controlled trial with two parallel
groups Study population: Pre-school children, aged 3-4 years living in Osun State area,
South-Western Nigeria. Children (n=750) will be screened for eligibility. Out of these, n=250
will undergo a 4-week run-in phase. n=200 children will be randomly allocated to two
different treatments: 1) Yellow cassava providing ~50% of the recommended daily allowance
(RDA) for vitamin A; 2) White cassava.
Main study parameters/endpoints: The primary outcome was the difference in body retinol pools
between groups 1 and 2 at the end of intervention; however, due to the inability to assess
body retinol pools, the modified primary outcome is the difference in serum retinol
concentrations between groups 1 and 2. Other outcome measures include: other vitamin A status
indicators (β-carotene, retinol binding protein, transthyretin), inflammatory markers, iron
status indicators, anthropometrics, gut integrity, and thyroid function.
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