The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
CASSAVITA II
1 other identifier
interventional
176
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 8, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 5, 2020
January 1, 2020
5 months
December 8, 2015
January 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Anaemia
13 weeks
Gut integrity
11 weeks
Other Outcomes (8)
Serum betacarotene
13 weeks
Retinol binding protein
13 weeks
Urinary thiocyanate
11 weeks
- +5 more other outcomes
Study Arms (2)
Treatment
ACTIVE COMPARATORDaily consumption of two cassava-based meals prepared with pro-vitamin A rich biofortified cassava
Control
PLACEBO COMPARATORDaily consumption of two cassava-based meals prepared with common white cassava
Interventions
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
Eligibility Criteria
You may qualify if:
- Aged 36 - 59 months (verified by birth certificates, vaccination cards or other formal documentation)
- Apparently healthy
- Parental informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Universitylead
- University of Ibadancollaborator
- International Institute for Tropical Agriculturecollaborator
Study Sites (1)
Department of Human Nutrition, University of Ibadan
Ibadan, Nigeria
Related Publications (1)
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.
PMID: 33184647DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alida Melse-Boonstra, PhD
Division of Human Nutrition, Wageningen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2015
First Posted
December 10, 2015
Study Start
December 1, 2015
Primary Completion
May 1, 2016
Study Completion
December 1, 2016
Last Updated
February 5, 2020
Record last verified: 2020-01