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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

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).

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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.

Conditions

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Vitamin A Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

Daily consumption of two cassava-based meals prepared with pro-vitamin A rich biofortified cassava

Group Type ACTIVE_COMPARATOR

Pro-vitamin A biofortified cassava

Intervention Type OTHER

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

Control

Daily consumption of two cassava-based meals prepared with common white cassava

Group Type PLACEBO_COMPARATOR

White cassava

Intervention Type OTHER

Conventional white cassava

Interventions

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Pro-vitamin A biofortified cassava

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

Intervention Type OTHER

White cassava

Conventional white cassava

Intervention Type OTHER

Other Intervention Names

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Yellow cassava Biofortified cassava Cassava Manihot esculenta

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

Minimum Eligible Age

36 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes