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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 indicators

Bioefficacy

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

Page last updated: August 20, 2015

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