Vitamin A DeficiencyCASSAVITANCT01614483
Efficacy of Yellow Cassava to Improve Vitamin A Status of Kenyan School Children
A study testing Yellow cassava and White cassava in people with Vitamin A Deficiency, run by Wageningen University at 1 site in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 61 months to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency
- What is being tested?
- Yellow cassava and White cassava
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 341 participants
- Where
- 1 siteKenya
- Study dates
- May 2012to Nov 2012
- 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 61 months to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Low vitamin A status (retinol binding protein (RBP) at the lowest end of the distribution will be included in the study)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin A Deficiency
- Being tested
- Yellow cassava, White cassava
- Keywords
- Vitamin A deficiency, Biofortification, Cassava, B-carotene, School children, Kenya
- 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.
Yellow cassavaOther
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
White cassavaOther
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
White cassavaOther
Daily provision of 375 g boiled white cassava for 18 weeks, 6 days/week Daily provision of B-carotene capsule (1400 µg B-carotene)
| Study group | Role | What they receive |
|---|---|---|
| Yellow cassava + placebo capsule | Experimental | Not described Receives: Other: Yellow cassava |
| White cassava + placebo capsule | Placebo comparator | Not described Receives: Other: White cassava |
| White cassava + B-carotene capsule | Active comparator | Not described Receives: Other: White cassava |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum retinol concentration
Measured: Baseline, end of study (4 months)
Secondary outcomes (6)
Immune function indicators
neopterin, IL-2, IL4, IL10, IL13, TNF-a, IFN-γ, TGF-β in serum; IgA in saliva
Measured: End of study (4 months)
Bioefficacy
Comparison of change in serum retinol between yellow cassava group and positive control (B-carotene supplement group)
Measured: Baseline, end of study (4 months)
Functional indicators
Gut integrity, dark adaptation, morbidity
Measured: End of study (4 months)
Thyroid function
Serum Tg, TSH
Measured: End of study (4 months
Effect modification
Serum zinc, serum retinol, iron status, polymorphisms
Measured: Baseline
Anemia
Hemoglobin
Measured: End of study (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, University of Nairobi
- Responsible party
- Principal investigator, Alida Melse, Wageningen University
- Investigators
- Alida Melse, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614483
- Sponsor's protocol ID
- INSTAPAWP2YC
- Acronym
- CASSAVITA
- Status last verified
- Nov 2022
- First submitted
- 1 Jun 2012
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Talsma EF, Brouwer ID, Verhoef H, Mbera GN, Mwangi AM, Demir AY, Maziya-Dixon B, Boy E, Zimmermann MB, Melse-Boonstra A. Biofortified yellow cassava and vitamin A status of Kenyan children: a randomized controlled trial. Am J Clin Nutr. 2016 Jan;103(1):258-67. doi: 10.3945/ajcn.114.100164. Epub 2015 Dec 16.
PubMed 26675768Talsma EF, Melse-Boonstra A, de Kok BP, Mbera GN, Mwangi AM, Brouwer ID. Biofortified cassava with pro-vitamin A is sensory and culturally acceptable for consumption by primary school children in Kenya. PLoS One. 2013 Aug 30;8(8):e73433. doi: 10.1371/journal.pone.0073433. eCollection 2013.
PubMed 24023681Talsma EF, Borgonjen-van den Berg KJ, Melse-Boonstra A, Mayer EV, Verhoef H, Demir AY, Ferguson EL, Kok FJ, Brouwer ID. The potential contribution of yellow cassava to dietary nutrient adequacy of primary-school children in Eastern Kenya; the use of linear programming. Public Health Nutr. 2018 Feb;21(2):365-376. doi: 10.1017/S1368980017002506. Epub 2017 Oct 2.
PubMed 28965533
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Yellow Cassava to Improve Vitamin A Status of Mildly Deficient Primary School Children in Kenya: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01614483
- Acronym / sponsor ID
- CASSAVITA / INSTAPAWP2YC
- Conditions
- Vitamin A Deficiency
- Keywords
- Vitamin A deficiency, Biofortification, Cassava, B-carotene, School children, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- European Commission, University of Nairobi
- Study start
- May 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Jun 2012 (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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yellow cassava + placebo capsule | Experimental | Other: Yellow cassava |
| White cassava + placebo capsule | Placebo comparator | Other: White cassava |
| White cassava + B-carotene capsule | Active comparator | Other: White cassava |
Who may qualify
- Ages
- 61 months to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Low vitamin A status (retinol binding protein (RBP) at the lowest end of the distribution will be included in the study)
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Yellow cassavaDaily 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 | Yellow cassava + placebo capsule |
| White cassavaDaily 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 + placebo capsule |
| White cassavaDaily provision of 375 g boiled white cassava for 18 weeks, 6 days/week Daily provision of B-carotene capsule (1400 µg B-carotene) | Other | White cassava + B-carotene capsule |
Primary outcome
Change in serum retinol concentration
Time frame: Baseline, end of study (4 months)
6 secondary outcomes
Immune function indicators
Time frame: End of study (4 months)
Bioefficacy
Time frame: Baseline, end of study (4 months)
Functional indicators
Time frame: End of study (4 months)
Thyroid function
Time frame: End of study (4 months
Effect modification
Time frame: Baseline
Anemia
Time frame: End of study (4 months)
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 21 Nov 2022.
- Background: PubMed 26675768Talsma EF, Brouwer ID, Verhoef H, Mbera GN, Mwangi AM, Demir AY, Maziya-Dixon B, Boy E, Zimmermann MB, Melse-Boonstra A. Biofortified yellow cassava and vitamin A status of Kenyan children: a randomized controlled trial. Am J Clin Nutr. 2016 Jan;103(1):258-67. doi: 10.3945/ajcn.114.100164. Epub 2015 Dec 16.
- Background: PubMed 24023681Talsma EF, Melse-Boonstra A, de Kok BP, Mbera GN, Mwangi AM, Brouwer ID. Biofortified cassava with pro-vitamin A is sensory and culturally acceptable for consumption by primary school children in Kenya. PLoS One. 2013 Aug 30;8(8):e73433. doi: 10.1371/journal.pone.0073433. eCollection 2013.
- Background: PubMed 28965533Talsma EF, Borgonjen-van den Berg KJ, Melse-Boonstra A, Mayer EV, Verhoef H, Demir AY, Ferguson EL, Kok FJ, Brouwer ID. The potential contribution of yellow cassava to dietary nutrient adequacy of primary-school children in Eastern Kenya; the use of linear programming. Public Health Nutr. 2018 Feb;21(2):365-376. doi: 10.1017/S1368980017002506. Epub 2017 Oct 2.
- Related InfoLink provided by the sponsor.
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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, PhD principal investigator
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 Yellow cassava and White cassava in people with Vitamin A Deficiency, run by Wageningen University at 1 site in Kenya.
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 1 inclusion and 2 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 21 Nov 2022. 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 Kenya. 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?
Change in serum retinol concentration (time frame: Baseline, end of study (4 months)). 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 NCT01614483, which also lists 3 linked publications.
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 21 Nov 2022.