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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vitamin A Deficiency

Intervention / Treatment
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* Other: Pro-vitamin A biofortified cassava
* Other: White cassava


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Daily consumption of two cassava-based meals prepared with pro-vitamin A rich biofortified cassava | Other: Pro-vitamin A biofortified cassava<br>* Pro-vitamin A biofortified cassava is the product of international conventional breeding programs (non-GMO) in order to increase the pro-vitamin A content of cassava for improved nutritional intake<br>* Other names: Biofortified cassava;|
| Placebo Comparator: Control<br>Daily consumption of two cassava-based meals prepared with common white cassava | Other: White cassava<br>* Conventional white cassava<br>* Other names: Manihot esculenta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body retinol pool (omitted) | Difference in body retinol pools between groups | 13 weeks | 
| (Modified primary outcome): Serum retinol | Difference in serum retinol pools between groups | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaemia | Difference in haemoglobin concentration between groups | 13 weeks | 
| Gut integrity | Difference in gut integrity between groups | 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pro-vitamin A, Cassava, Vitamin A deficiency, Retinol Isotope Dilution, Preschool children, Nigeria