Efficacy of Yellow Cassava to Improve Vitamin A Status of Kenyan School Children (CASSAVITA)

This study has been completed.
Sponsor:
Collaborators:
European Commission
University of Nairobi
Information provided by (Responsible Party):
Alida Melse, Wageningen University
ClinicalTrials.gov Identifier:
NCT01614483
First received: June 1, 2012
Last updated: January 29, 2013
Last verified: January 2013

June 1, 2012
January 29, 2013
May 2012
November 2012   (final data collection date for primary outcome measure)
Change in serum retinol concentration [ Time Frame: Baseline, end of study (4 months) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01614483 on ClinicalTrials.gov Archive Site
  • Immune function indicators [ Time Frame: End of study (4 months) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Gut integrity, dark adaptation, morbidity
  • Thyroid function [ Time Frame: End of study (4 months ] [ Designated as safety issue: No ]
    Serum Tg, TSH
  • Effect modification [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Serum zinc, serum retinol, iron status, polymorphisms
  • Anemia [ Time Frame: End of study (4 months) ] [ Designated as safety issue: No ]
    Hemoglobin
Same as current
Not Provided
Not Provided
 
Efficacy of Yellow Cassava to Improve Vitamin A Status of Kenyan School Children
Efficacy of Yellow Cassava to Improve Vitamin A Status of Mildly Deficient Primary School Children in Kenya: a Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Vitamin A Deficiency
  • 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
  • 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
  • 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)
  • Experimental: Yellow cassava + placebo capsule
    Intervention: Other: Yellow cassava
  • Placebo Comparator: White cassava + placebo capsule
    Intervention: Other: White cassava
  • Active Comparator: White cassava + B-carotene capsule
    Intervention: Other: White cassava
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
341
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
61 Months to 13 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01614483
INSTAPAWP2YC
Yes
Alida Melse, Wageningen University
Wageningen University
  • European Commission
  • University of Nairobi
Principal Investigator: Alida Melse, PhD Wageningen University
Wageningen University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP