Clinical Trial: The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children

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 Summary:

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 is the difference in body retinol pools between groups 1 and 2 at the end of intervention. 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.


Sponsor: Wageningen University

Current Primary Outcome: Body retinol pool [ Time Frame: 10 weeks ]

Difference in body retinol pools between groups


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Anaemia [ Time Frame: 10 weeks ]
    Difference in haemoglobin concentration between groups
  • Gut integrity [ Time Frame: 8 weeks ]
    Difference in gut integrity between groups


Original Secondary Outcome: Same as current

Information By: Wageningen University

Dates:
Date Received: December 8, 2015
Date Started: December 2015
Date Completion: December 2016
Last Updated: November 11, 2016
Last Verified: November 2016