The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
- Conditions
- Vitamin A Deficiency
- Interventions
- Other: Pro-vitamin A biofortified cassavaOther: White cassava
- Registration Number
- NCT02627222
- Lead Sponsor
- Wageningen University
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
- Aged 36 - 59 months (verified by birth certificates, vaccination cards or other formal documentation)
- Apparently healthy
- Parental informed consent
- Frequently absent (>20% of feeding days) during run-in
- Children not assenting during blood collections
- Signs or history of infectious or systemic diseases (e.g. tuberculosis, sickle cell anaemia)
- Mental status that is incompatible with the proper conduct of the study
- Current participation in other research
- Food allergy related to the intervention foods
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Pro-vitamin A biofortified cassava Daily consumption of two cassava-based meals prepared with pro-vitamin A rich biofortified cassava Control White cassava Daily consumption of two cassava-based meals prepared with common white cassava
- Primary Outcome Measures
Name Time Method Body retinol pool (omitted) 13 weeks Difference in body retinol pools between groups
(Modified primary outcome): Serum retinol 13 weeks Difference in serum retinol pools between groups
- Secondary Outcome Measures
Name Time Method Anaemia 13 weeks Difference in haemoglobin concentration between groups
Gut integrity 11 weeks Difference in gut integrity between groups
Trial Locations
- Locations (1)
Department of Human Nutrition, University of Ibadan
🇳🇬Ibadan, Nigeria