Efficacy of Yellow Cassava to Improve Vitamin A Status of Kenyan School Children
Information source: Wageningen University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin A Deficiency
Intervention: Yellow cassava (Other); White cassava (Other); White cassava (Other)
Phase: N/A
Status: Completed
Sponsored by: Wageningen University Official(s) and/or principal investigator(s): Alida Melse, PhD, Principal Investigator, Affiliation: Wageningen University
Summary
The overall aim of the project is to provide proof-of-principle that biofortification of
cassava with vitamin A is a viable strategy to improve vitamin A status of deficient
populations.
Clinical Details
Official title: Efficacy of Yellow Cassava to Improve Vitamin A Status of Mildly Deficient Primary School Children in Kenya: a Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Change in serum retinol concentration
Secondary outcome: Immune function indicatorsBioefficacy Functional indicators Thyroid function Effect modification Anemia
Detailed description:
Rationale: Vitamin A deficiency is still common in developing countries and has been proven
difficult to combat. A promising approach is to replace common crops with varieties that are
naturally richer in vitamin A, which is referred to as biofortification. For cassava, yellow
β-carotene rich varieties have recently been introduced in Kenya, and these varieties are
now ready to be tested for their efficacy to improve vitamin A status in humans.
Objective: The primary objective is to measure the effect of daily consumption of provitamin
A biofortified cassava (providing 50% of the age-specific RDA) on vitamin A status in
children aged 5-13 years with mild to moderate vitamin A deficiency in Kenya. To determine
the bioefficacy of provitamin A carotenoids from biofortified cassava relative to that of a
daily B-carotene supplement (comparison with positive control group). Secondary objectives
are: 1) to measure the effect of the intervention on immune function indicators and
morbidity; 2) to determine to what degree the serum retinol response to the intervention
depends on serum concentrations of retinol and zinc at baseline; 3) to determine the effect
of the intervention on functional indicators such as dark adaptation capacity, gut
integrity, hematology indicators and thyroid status; 4) to determine the mediating effect of
SNP's in the BCMO1 gene on treatment outcome.
Study design & Study population : In this randomized controlled trial, school children aged
5-13 years living in the Kibwezi area, Kenya. Children will be selected from three (or four)
primary schools in the area that have been pre-selected based on the prevalence of vitamin A
deficiency, location and willingness to participate.
Intervention: After screening for eligibility and a 2-week run-in period (n=360) Children
will be randomly allocated to three different treatments: 1) 400 g of yellow cassava
providing ~50% of the RDA for vitamin A; and a placebo capsule; 2) 400 g of white cassava;
and a placebo capsule; 3) 400 g of white cassava and a capsule containing 100 RAE of
all-trans β-carotene.
Main study parameters/endpoints: The main outcome measure will be differences in serum
retinol concentrations between groups. Other outcome measures include other vitamin A status
indicators (β-carotene, retinol binding protein, transthyretin), immune function indicators,
dark adaptation, iron status indicators, anthropometrics, gut integrity, and thyroid
function.
Eligibility
Minimum age: 61 Months.
Maximum age: 13 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Low vitamin A status (retinol binding protein (RBP) at the lowest end of the
distribution will be included in the study)
Exclusion Criteria:
- History or signs of infectious or systemic diseases (e. g. tuberculosis, sickle cell
anaemia)
- Anaemia, malaria or acute inflammation at the day of baseline measurements
Locations and Contacts
Kibwezi District, Kibwezi, Eastern Kenya, Kenya
Additional Information
Starting date: May 2012
Last updated: January 29, 2013
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