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

Vitamin A Deficiency Clinical Trial

— CASSAVITA II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627222
• Other study ID #: CASSAVITA II
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2020
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Night Blindness
• Vitamin A Deficiency

Intervention

Other:
• 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
• White cassava
Conventional white cassava

Locations

Country	Name	City	State
Nigeria	Department of Human Nutrition, University of Ibadan	Ibadan

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	International Institute for Tropical Agriculture, University of Ibadan

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum betacarotene	Difference in serum retinol concentration between groups	13 weeks
Other	Retinol binding protein	Difference in serum retinol binding protein concentration between groups	13 weeks
Other	Urinary thiocyanate	Difference in urinary thiocyanate concentration between groups	11 weeks
Other	Thyroid function indicators	Difference in serum thyroid function indicators between groups	13 weeks
Other	Serum zinc	Effect modification by baseline zinc deficiency	Baseline
Other	Genetic polymorphisms in the BCO1 gene	Effect modification by BCO1 polymorphisms	Baseline
Other	Inflammatory markers	C-reactive protein, alpha glycoprotein	Baseline and end of study
Other	Malaria	A-symptomatic malaria	Baseline and end of study
Primary	Body retinol pool (omitted)	Difference in body retinol pools between groups	13 weeks
Primary	(Modified primary outcome): Serum retinol	Difference in serum retinol pools between groups	13 weeks
Secondary	Anaemia	Difference in haemoglobin concentration between groups	13 weeks
Secondary	Gut integrity	Difference in gut integrity between groups	11 weeks