The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children (CASSAVITA II)
Primary Purpose
Vitamin A Deficiency
Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Pro-vitamin A biofortified cassava
White cassava
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin A Deficiency focused on measuring Pro-vitamin A, Cassava, Vitamin A deficiency, Retinol Isotope Dilution, Preschool children, Nigeria
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
Sites / Locations
- Department of Human Nutrition, University of Ibadan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment
Control
Arm Description
Daily consumption of two cassava-based meals prepared with pro-vitamin A rich biofortified cassava
Daily consumption of two cassava-based meals prepared with common white cassava
Outcomes
Primary Outcome Measures
Body retinol pool (omitted)
Difference in body retinol pools between groups
(Modified primary outcome): Serum retinol
Difference in serum retinol pools between groups
Secondary Outcome Measures
Anaemia
Difference in haemoglobin concentration between groups
Gut integrity
Difference in gut integrity between groups
Full Information
NCT ID
NCT02627222
First Posted
December 8, 2015
Last Updated
January 31, 2020
Sponsor
Wageningen University
Collaborators
University of Ibadan, International Institute for Tropical Agriculture
1. Study Identification
Unique Protocol Identification Number
NCT02627222
Brief Title
The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
Acronym
CASSAVITA II
Official Title
The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University
Collaborators
University of Ibadan, International Institute for Tropical Agriculture
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency
Keywords
Pro-vitamin A, Cassava, Vitamin A deficiency, Retinol Isotope Dilution, Preschool children, Nigeria
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Daily consumption of two cassava-based meals prepared with pro-vitamin A rich biofortified cassava
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Daily consumption of two cassava-based meals prepared with common white cassava
Intervention Type
Other
Intervention Name(s)
Pro-vitamin A biofortified cassava
Other Intervention Name(s)
Yellow cassava, Biofortified cassava
Intervention Description
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
Intervention Name(s)
White cassava
Other Intervention Name(s)
Cassava, Manihot esculenta
Intervention Description
Conventional white cassava
Primary Outcome Measure Information:
Title
Body retinol pool (omitted)
Description
Difference in body retinol pools between groups
Time Frame
13 weeks
Title
(Modified primary outcome): Serum retinol
Description
Difference in serum retinol pools between groups
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Anaemia
Description
Difference in haemoglobin concentration between groups
Time Frame
13 weeks
Title
Gut integrity
Description
Difference in gut integrity between groups
Time Frame
11 weeks
Other Pre-specified Outcome Measures:
Title
Serum betacarotene
Description
Difference in serum retinol concentration between groups
Time Frame
13 weeks
Title
Retinol binding protein
Description
Difference in serum retinol binding protein concentration between groups
Time Frame
13 weeks
Title
Urinary thiocyanate
Description
Difference in urinary thiocyanate concentration between groups
Time Frame
11 weeks
Title
Thyroid function indicators
Description
Difference in serum thyroid function indicators between groups
Time Frame
13 weeks
Title
Serum zinc
Description
Effect modification by baseline zinc deficiency
Time Frame
Baseline
Title
Genetic polymorphisms in the BCO1 gene
Description
Effect modification by BCO1 polymorphisms
Time Frame
Baseline
Title
Inflammatory markers
Description
C-reactive protein, alpha glycoprotein
Time Frame
Baseline and end of study
Title
Malaria
Description
A-symptomatic malaria
Time Frame
Baseline and end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alida Melse-Boonstra, PhD
Organizational Affiliation
Division of Human Nutrition, Wageningen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition, University of Ibadan
City
Ibadan
Country
Nigeria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33184647
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.
Results Reference
derived
Learn more about this trial
The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
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