Efficacy of Yellow Cassava to Improve Vitamin A Status of Kenyan School Children (CASSAVITA)
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|ClinicalTrials.gov Identifier: NCT01614483|
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : January 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Vitamin A Deficiency||Other: Yellow cassava Other: White cassava||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||341 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Yellow Cassava to Improve Vitamin A Status of Mildly Deficient Primary School Children in Kenya: a Randomized Controlled Trial|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
|Experimental: Yellow cassava + placebo capsule||
Other: Yellow cassava
Daily provision of 375 g boiled yellow cassava for 18 weeks, 6 days/week Daily provision of placebo capsule for 18 weeks, 6 days/week
|Placebo Comparator: White cassava + placebo capsule||
Other: White cassava
Daily provision of 375 g boiled white cassava for 18 weeks, 6 days/ week Daily provision of placebo capsule for 18 weeks, 6 days/ week
|Active Comparator: White cassava + B-carotene capsule||
Other: White cassava
Daily provision of 375 g boiled white cassava for 18 weeks, 6 days/week Daily provision of B-carotene capsule (1400 µg B-carotene)
- Change in serum retinol concentration [ Time Frame: Baseline, end of study (4 months) ]
- Immune function indicators [ Time Frame: End of study (4 months) ]neopterin, IL-2, IL4, IL10, IL13, TNF-a, IFN-γ, TGF-β in serum; IgA in saliva
- Bioefficacy [ Time Frame: Baseline, end of study (4 months) ]Comparison of change in serum retinol between yellow cassava group and positive control (B-carotene supplement group)
- Functional indicators [ Time Frame: End of study (4 months) ]Gut integrity, dark adaptation, morbidity
- Thyroid function [ Time Frame: End of study (4 months ]Serum Tg, TSH
- Effect modification [ Time Frame: Baseline ]Serum zinc, serum retinol, iron status, polymorphisms
- Anemia [ Time Frame: End of study (4 months) ]Hemoglobin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614483
|Kibwezi, Eastern Kenya, Kenya|
|Principal Investigator:||Alida Melse, PhD||Wageningen University|