Clinical trial NCT02627222: The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
Official title: The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin A Deficiency
Keywords: Pro-vitamin A
Cassava
Vitamin A deficiency
Retinol Isotope Dilution
Preschool children
Nigeria
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: University of Ibadan
name: International Institute for Tropical Agriculture
First posted: 2015-12-10
Enrollment: 176
Sex: ALL
Minimum age (years): 36
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Aged 36 - 59 months (verified by birth certificates, vaccination cards or other formal documentation)
* Apparently healthy
* Parental informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Body retinol pool (omitted)
timeFrame: 13 weeks
measure: (Modified primary outcome): Serum retinol
timeFrame: 13 weeks
Secondary outcomes:
measure: Anaemia
timeFrame: 13 weeks
measure: Gut integrity
timeFrame: 11 weeks
Other outcomes:
measure: Serum betacarotene
timeFrame: 13 weeks
measure: Retinol binding protein
timeFrame: 13 weeks
measure: Urinary thiocyanate
timeFrame: 11 weeks
measure: Thyroid function indicators
timeFrame: 13 weeks
measure: Serum zinc
timeFrame: Baseline
measure: Genetic polymorphisms in the BCO1 gene
timeFrame: Baseline
measure: Inflammatory markers
timeFrame: Baseline and end of study
measure: Malaria
timeFrame: Baseline and end of study
Locations:
city: Ibadan
country: Nigeria
facility: Department of Human Nutrition, University of Ibadan
Study officials:
affiliation: Division of Human Nutrition, Wageningen University
name: Alida Melse-Boonstra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Afolami I, Mwangi MN, Samuel F, Boy E, Ilona P, Talsma EF, Feskens E, Melse-Boonstra A. Daily consumption of pro-vitamin A biofortified (yellow) cassava improves serum retinol concentrations in preschool children in Nigeria: a randomized controlled trial. Am J Clin Nutr. 2021 Jan 4;113(1):221-231. doi: 10.1093/ajcn/nqaa290.