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The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children (CASSAVITA II)

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ClinicalTrials.gov Identifier: NCT02627222
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : August 25, 2017
Sponsor:
Collaborators:
University of Ibadan
International Institute for Tropical Agriculture
Information provided by (Responsible Party):
Wageningen University

Brief Summary:
The study comprises an open-label randomized controlled trial investigating the efficacy of consuming a daily ration of pro-vitamin A biofortified cassava on vitamin A status of Nigerian children, aged 3-4 years old (n=200).

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency Other: Pro-vitamin A biofortified cassava Other: White cassava Not Applicable

Detailed Description:

Objective: The primary objective is to assess the efficacy of daily consumption of pro-vitamin A rich cassava during 10 weeks on body retinol pools of 3-4 year old children in Nigeria after high-dose vitamin A supplementation. The secondary objectives are: 1) To investigate the effect of daily consumption of pro-vitamin A rich cassava on functional indicators such as nutritional anaemia and gut integrity; 2) To investigate the effect of zinc deficiency and genetic polymorphisms in the Beta-Carotene Oxygenase 1 (BCO1) and related genes on the efficacy of pro-vitamin A rich cassava consumption; 3) To compare the skin colour in the palm of the hand of each participant with their serum retinol levels using a handheld non-invasive spectrophotometer.

Study design: Open-label (single-blinded) randomized controlled trial with two parallel groups Study population: Pre-school children, aged 3-4 years living in Osun State area, South-Western Nigeria. Children (n=750) will be screened for eligibility. Out of these, n=250 will undergo a 4-week run-in phase. n=200 children will be randomly allocated to two different treatments: 1) Yellow cassava providing ~50% of the recommended daily allowance (RDA) for vitamin A; 2) White cassava.

Main study parameters/endpoints: The primary outcome is the difference in body retinol pools between groups 1 and 2 at the end of intervention. Other outcome measures include: other vitamin A status indicators (β-carotene, retinol binding protein, transthyretin), inflammatory markers, iron status indicators, anthropometrics, gut integrity, and thyroid function.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
Study Start Date : December 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Active Comparator: Treatment
Daily consumption of two cassava-based meals prepared with pro-vitamin A rich biofortified cassava
Other: Pro-vitamin A biofortified cassava
Pro-vitamin A biofortified cassava is the product of international conventional breeding programs (non-GMO) in order to increase the pro-vitamin A content of cassava for improved nutritional intake
Other Names:
  • Yellow cassava
  • Biofortified cassava

Placebo Comparator: Control
Daily consumption of two cassava-based meals prepared with common white cassava
Other: White cassava
Conventional white cassava
Other Names:
  • Cassava
  • Manihot esculenta




Primary Outcome Measures :
  1. Body retinol pool [ Time Frame: 10 weeks ]
    Difference in body retinol pools between groups


Secondary Outcome Measures :
  1. Anaemia [ Time Frame: 10 weeks ]
    Difference in haemoglobin concentration between groups

  2. Gut integrity [ Time Frame: 8 weeks ]
    Difference in gut integrity between groups


Other Outcome Measures:
  1. Serum retinol [ Time Frame: 10 weeks ]
    Difference in serum retinol concentration between groups

  2. Serum betacarotene [ Time Frame: 10 weeks ]
    Difference in serum retinol concentration between groups

  3. Retinol binding protein [ Time Frame: 10 weeks ]
    Difference in serum retinol binding protein concentration between groups

  4. Urinary thiocyanate [ Time Frame: 8 weeks ]
    Difference in urinary thiocyanate concentration between groups

  5. Thyroid function indicators [ Time Frame: 10 weeks ]
    Difference in serum thyroid function indicators between groups

  6. Serum zinc [ Time Frame: Baseline ]
    Effect modification by baseline zinc deficiency

  7. Genetic polymorphisms in the BCO1 gene [ Time Frame: Baseline ]
    Effect modification by BCO1 polymorphisms

  8. Inflammatory markers [ Time Frame: Baseline and end of study ]
    C-reactive protein, alpha glycoprotein

  9. Malaria [ Time Frame: Baseline and end of study ]
    A-symptomatic malaria



Information from the National Library of Medicine

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Ages Eligible for Study:   36 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 36 - 59 months (verified by birth certificates, vaccination cards or other formal documentation)
  • Apparently healthy
  • Parental informed consent

Exclusion Criteria:

  • Frequently absent (>20% of feeding days) during run-in
  • Children not assenting during blood collections
  • Signs or history of infectious or systemic diseases (e.g. tuberculosis, sickle cell anaemia)
  • Mental status that is incompatible with the proper conduct of the study
  • Current participation in other research
  • Food allergy related to the intervention foods

Information from the National Library of Medicine

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): NCT02627222


Locations
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Nigeria
Department of Human Nutrition, University of Ibadan
Ibadan, Nigeria
Sponsors and Collaborators
Wageningen University
University of Ibadan
International Institute for Tropical Agriculture
Investigators
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Principal Investigator: Alida Melse-Boonstra, PhD Division of Human Nutrition, Wageningen University

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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT02627222     History of Changes
Other Study ID Numbers: CASSAVITA II
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Wageningen University:
Pro-vitamin A
Cassava
Vitamin A deficiency
Retinol Isotope Dilution
Preschool children
Nigeria

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