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
  Purpose

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.


Condition Intervention
Vitamin A Deficiency
Other: Yellow cassava
Other: White cassava

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Yellow Cassava to Improve Vitamin A Status of Mildly Deficient Primary School Children in Kenya: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Change in serum retinol concentration [ Time Frame: Baseline, end of study (4 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 341
Study Start Date: May 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   61 Months to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614483

Locations
Kenya
Kibwezi District
Kibwezi, Eastern Kenya, Kenya
Sponsors and Collaborators
Wageningen University
European Commission
University of Nairobi
Investigators
Principal Investigator: Alida Melse, PhD Wageningen University
  More Information

Additional Information:
No publications provided

Responsible Party: Alida Melse, PhD, Wageningen University
ClinicalTrials.gov Identifier: NCT01614483     History of Changes
Other Study ID Numbers: INSTAPAWP2YC
Study First Received: June 1, 2012
Last Updated: January 29, 2013
Health Authority: Kenya: Pharmacy and Poisons Board

Keywords provided by Wageningen University:
Vitamin A deficiency
Biofortification
Cassava
B-carotene
School children
Kenya

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamin A
Vitamins
Beta Carotene
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014