Vitamin A DeficiencyCASSAVITA IINCT02627222
The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
A study testing Pro-vitamin A biofortified cassava and White cassava in people with Vitamin A Deficiency, run by Wageningen University at 1 site in Nigeria.
Trial 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). Read more about this study
- Who is it for?
- Ages 36 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency
- What is being tested?
- Pro-vitamin A biofortified cassava and White cassava
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteNigeria
- Study dates
- Dec 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 36 - 59 months (verified by birth certificates, vaccination cards or other formal documentation)
- Apparently healthy
- Parental informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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 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.
- Conditions
- Vitamin A Deficiency
- Being tested
- Pro-vitamin A biofortified cassava, White cassava
- Keywords
- Pro-vitamin A, Cassava, Vitamin A deficiency, Retinol Isotope Dilution, Preschool children, Nigeria
- Medical subject headings
- Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-vitamin A biofortified cassavaOther
Also called Yellow cassava, 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
White cassavaOther
Also called Cassava, Manihot esculenta
Conventional white cassava
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Daily consumption of two cassava-based meals prepared with pro-vitamin A rich biofortified cassava Receives: Other: Pro-vitamin A biofortified cassava |
| Control | Placebo comparator | Daily consumption of two cassava-based meals prepared with common white cassava Receives: Other: White cassava |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body retinol pool (omitted)
Difference in body retinol pools between groups
Measured: 13 weeks
(Modified primary outcome): Serum retinol
Difference in serum retinol pools between groups
Measured: 13 weeks
Secondary outcomes (2)
Anaemia
Difference in haemoglobin concentration between groups
Measured: 13 weeks
Gut integrity
Difference in gut integrity between groups
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ibadan, International Institute for Tropical Agriculture
- Responsible party
- Sponsor
- Investigators
- Alida Melse-Boonstra, PhD, Principal investigator, Division of Human Nutrition, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627222
- Sponsor's protocol ID
- CASSAVITA II
- Acronym
- CASSAVITA II
- Status last verified
- Jan 2020
- First submitted
- 8 Dec 2015
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Afolami I, Mwangi MN, Samuel F, Boy E, Ilona P, Talsma EF, Feskens E, Melse-Boonstra A. Daily consumption of pro-vitamin A biofortified (yellow) cassava improves serum retinol concentrations in preschool children in Nigeria: a randomized controlled trial. Am J Clin Nutr. 2021 Jan 4;113(1):221-231. doi: 10.1093/ajcn/nqaa290.
PubMed 33184647
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
- ClinicalTrials.gov ID
- NCT02627222
- Acronym / sponsor ID
- CASSAVITA II / CASSAVITA II
- Conditions
- Vitamin A Deficiency
- Keywords
- Pro-vitamin A, Cassava, Vitamin A deficiency, Retinol Isotope Dilution, Preschool children, Nigeria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- University of Ibadan, International Institute for Tropical Agriculture
- Study start
- Dec 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Other: Pro-vitamin A biofortified cassavaDaily consumption of two cassava-based meals prepared with pro-vitamin A rich biofortified cassava |
| Control | Placebo comparator | Other: White cassavaDaily consumption of two cassava-based meals prepared with common white cassava |
Who may qualify
- Ages
- 36 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 36 - 59 months (verified by birth certificates, vaccination cards or other formal documentation)
- Apparently healthy
- Parental informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro-vitamin A biofortified cassavaAlso: Yellow cassava, Biofortified cassavaPro-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 | Treatment |
| White cassavaAlso: Cassava, Manihot esculentaConventional white cassava | Other | Control |
Primary outcome
Body retinol pool (omitted)
Time frame: 13 weeks
Difference in body retinol pools between groups
(Modified primary outcome): Serum retinol
Time frame: 13 weeks
Difference in serum retinol pools between groups
2 secondary outcomes
Anaemia
Time frame: 13 weeks
Gut integrity
Time frame: 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 33184647Afolami I, Mwangi MN, Samuel F, Boy E, Ilona P, Talsma EF, Feskens E, Melse-Boonstra A. Daily consumption of pro-vitamin A biofortified (yellow) cassava improves serum retinol concentrations in preschool children in Nigeria: a randomized controlled trial. Am J Clin Nutr. 2021 Jan 4;113(1):221-231. doi: 10.1093/ajcn/nqaa290.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alida Melse-Boonstra, PhD principal investigator
Division of Human Nutrition, Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pro-vitamin A biofortified cassava and White cassava in people with Vitamin A Deficiency, run by Wageningen University at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body retinol pool (omitted) (time frame: 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.