An interventional study of Pro-vitamin A biofortified cassava and White cassava in Vitamin A Deficiency, sponsored by Wageningen University. Completed at 1 site in Nigeria. Open to participants aged 36 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Wageningen University · Not applicable, Interventional, and Prevention
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).
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 was the difference in body retinol pools between groups 1 and 2 at the end of intervention; however, due to the inability to assess body retinol pools, the modified primary outcome is the difference in serum retinol concentrations between groups 1 and 2. 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.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 176 is below the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →Wageningen University is the lead sponsor of 153 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily consumption of two cassava-based meals prepared with pro-vitamin A rich biofortified cassava
Other: Pro-vitamin A biofortified cassava
Daily consumption of two cassava-based meals prepared with common white cassava
Other: White 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
Also known as: Yellow cassava, Biofortified cassava
Conventional white cassava
Also known as: Cassava, Manihot esculenta
Body retinol pool (omitted)
Difference in body retinol pools between groups
Time frame: 13 weeks
(Modified primary outcome): Serum retinol
Difference in serum retinol pools between groups
Time frame: 13 weeks
Anaemia
Difference in haemoglobin concentration between groups
Time frame: 13 weeks
Gut integrity
Difference in gut integrity between groups
Time frame: 11 weeks
Serum betacarotene
Difference in serum retinol concentration between groups
Time frame: 13 weeks
Retinol binding protein
Difference in serum retinol binding protein concentration between groups
Time frame: 13 weeks
Urinary thiocyanate
Difference in urinary thiocyanate concentration between groups
Time frame: 11 weeks
Thyroid function indicators
Difference in serum thyroid function indicators between groups
Time frame: 13 weeks
Serum zinc
Effect modification by baseline zinc deficiency
Time frame: Baseline
Genetic polymorphisms in the BCO1 gene
Effect modification by BCO1 polymorphisms
Time frame: Baseline
Inflammatory markers
C-reactive protein, alpha glycoprotein
Time frame: Baseline and end of study
Malaria
A-symptomatic malaria
Time frame: Baseline and end of study
Plan to share: Undecided
The record gives a start of Dec 2015, a primary completion of May 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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