Vitamin A DeficiencyPhase 3NCT01695148
Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children
A Phase 3 study testing β-Carotene Biofortified Maize Flour and White Maize Flour in people with Vitamin A Deficiency and Low Serum Retinol, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Zambia.
Trial summary
The purpose of this cluster-randomized trial is to examine whether daily consumption of β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and improve the vitamin A status and among 4-8 year old children in rural Zambia. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency, Low Serum Retinol
- What is being tested?
- β-Carotene Biofortified Maize Flour and White Maize Flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,228 participants
- Where
- 1 siteZambia
- Study dates
- Aug 2012to Jun 2013
- Phase
- Phase 3
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 4-8 years of age
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of β-carotene Biofortified Maize in Improving Vitamin A Status and Reducing the Prevalence of Vitamin A Deficiency Among Children in Rural Zambia
The purpose of this cluster-randomized trial is to examine whether daily consumption of β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and improve the vitamin A status and among 4-8 year old children in rural Zambia.
Read the detailed description
Vitamin A deficiency is a major public health problem in Zambia, affecting approximately 40% of young children. We aim to conduct a cluster-randomised controlled trial in the Mkushi region of rural Zambia to test whether feeding children two daily meals containing β-carotene biofortified maize flour compared to regular white maize flour-based meals for six months can reduce the prevalence of vitamin A deficiency and improve the vitamin A status among 4-8 year old children. Five hundred children in each arm will receive 2 meals a day, 6 days a week for 6 months, after which changes in serum retinol concentrations will be compared. An additional arm of 250 children, enrolled from randomly sampled clusters, will not receive the maize flour intervention but concurrently followed in order to evaluate overall effects of the maize flour feeding scheme on measures of household food security.
- Conditions
- Vitamin A Deficiency, Low Serum Retinol
- Being tested
- β-Carotene Biofortified Maize Flour, White Maize Flour
- Keywords
- beta-carotene biofortified maize, micronutrients, vitamin A, serum retinol, dark adaptation
- 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.
β-Carotene Biofortified Maize FlourDietary supplement
White Maize FlourDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| White Maize Flour | Active comparator | Children will receive 2 meals a day (~200 g of white maize flour), 6 days a week for 6 months. Receives: Dietary Supplement: White Maize Flour |
| β-Carotene Biofortified Maize | Experimental | Children will receive 2 meals a day (~200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months. Receives: Dietary Supplement: β-Carotene Biofortified Maize Flour |
| Non-Intervened | No intervention | Children will receive no food for the duration of the study, but families in this group will receive an equivalent ration of food items at the end of the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased Serum Retinol Concentration
The investigators hypothesize a difference of 2.5 μg/dL or more in serum retinol among children receiving biofortified versus white maize flour-based meals. Serum retinol measures will be collected at baseline and at the end of 6 months and assessed by a High Performance Liquid Chromatography assay.
Measured: After 6 months of feeding
Decreased Prevalence of Vitamin A deficiency
The investigators hypothesize a difference of 10% or more in the prevalence of vitamin A deficiency (i.e., serum retinol < 0.7 μmol/l) among children consuming biofortified versus white maize flour-based meals, assuming a baseline prevalence of 40%.
Measured: After 6 months of feeding
Secondary outcomes (1)
Improved Dark Adaptation
The investigators hypothesize a difference in pupillary response to a light stimulus, as detected by dark adaptometry, in children receiving biofortified versus white maize flour-based meals.
Measured: After 6 months of Feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Food and Nutrition Commission, Zambia, Tropical Diseases Research Centre, Zambia, HarvestPlus, Canadian International Development Agency, Zambia Agriculture Research Institute
- Responsible party
- Principal investigator, Keith P. West, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Amanda C Palmer, PhD, Study director, Johns Hopkins Bloomberg School of Public HealthRolf Klemm, DrPH, Study director, Johns Hopkins Bloomberg School of Public HealthKerry J Schulze, PhD, Study director, Johns Hopkins Bloomberg School of Public HealthAlain Labrique, PhD, Study director, Johns Hopkins Bloomberg School of Public HealthParul Christian, DrPH, Study director, Johns Hopkins Bloomberg School of Public HealthSucheta Mehra, MS, Study director, Johns Hopkins Bloomberg School of Public HealthLee Shu-Fune Wu, MS, Study director, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695148
- Sponsor's protocol ID
- JHU IRB 4150
- Status last verified
- Feb 2014
- First submitted
- 25 Sep 2012
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Howe JA, Tanumihardjo SA. Carotenoid-biofortified maize maintains adequate vitamin a status in Mongolian gerbils. J Nutr. 2006 Oct;136(10):2562-7. doi: 10.1093/jn/136.10.2562.
PubMed 16988127Howe JA, Tanumihardjo SA. Evaluation of analytical methods for carotenoid extraction from biofortified maize (Zea mays sp.). J Agric Food Chem. 2006 Oct 18;54(21):7992-7. doi: 10.1021/jf062256f.
PubMed 17032000Davis C, Jing H, Howe JA, Rocheford T, Tanumihardjo SA. beta-Cryptoxanthin from supplements or carotenoid-enhanced maize maintains liver vitamin A in Mongolian gerbils ( Meriones unguiculatus) better than or equal to beta-carotene supplements. Br J Nutr. 2008 Oct;100(4):786-93. doi: 10.1017/S0007114508944123. Epub 2008 Mar 3.
PubMed 18312712Davis CR, Howe JA, Rocheford TR, Tanumihardjo SA. The xanthophyll composition of biofortified maize (Zea mays Sp.) does not influence the bioefficacy of provitamin a carotenoids in Mongolian gerbils (Meriones unguiculatus). J Agric Food Chem. 2008 Aug 13;56(15):6745-50. doi: 10.1021/jf800816q. Epub 2008 Jul 11.
PubMed 18616269Muzhingi T, Gadaga TH, Siwela AH, Grusak MA, Russell RM, Tang G. Yellow maize with high beta-carotene is an effective source of vitamin A in healthy Zimbabwean men. Am J Clin Nutr. 2011 Aug;94(2):510-9. doi: 10.3945/ajcn.110.006486. Epub 2011 Jun 29.
PubMed 21715509Healy K, Palmer AC, Barffour MA, Schulze KJ, Siamusantu W, Chileshe J, West KP Jr, Labrique AB. Nutritional Status Measures Are Correlated with Pupillary Responsiveness in Zambian Children. J Nutr. 2018 Jul 1;148(7):1160-1166. doi: 10.1093/jn/nxy069.
PubMed 29924320Palmer AC, Craft NE, Schulze KJ, Barffour M, Chileshe J, Siamusantu W, West KP Jr. Impact of biofortified maize consumption on serum carotenoid concentrations in Zambian children. Eur J Clin Nutr. 2018 Feb;72(2):301-303. doi: 10.1038/s41430-017-0054-1. Epub 2018 Jan 10.
PubMed 29321687Barffour MA, Schulze KJ, Coles CL, Chileshe J, Kalungwana N, Arguello M, Siamusantu W, Moss WJ, West KP Jr, Palmer AC. High Iron Stores in the Low Malaria Season Increase Malaria Risk in the High Transmission Season in a Prospective Cohort of Rural Zambian Children. J Nutr. 2017 Aug;147(8):1531-1536. doi: 10.3945/jn.117.250381. Epub 2017 Jul 12.
PubMed 28701387Palmer AC, Healy K, Barffour MA, Siamusantu W, Chileshe J, Schulze KJ, West KP Jr, Labrique AB. Provitamin A Carotenoid-Biofortified Maize Consumption Increases Pupillary Responsiveness among Zambian Children in a Randomized Controlled Trial. J Nutr. 2016 Dec;146(12):2551-2558. doi: 10.3945/jn.116.239202. Epub 2016 Oct 19.
PubMed 27798345Palmer AC, Siamusantu W, Chileshe J, Schulze KJ, Barffour M, Craft NE, Molobeka N, Kalungwana N, Arguello MA, Mitra M, Caswell B, Klemm RD, West KP Jr. Provitamin A-biofortified maize increases serum beta-carotene, but not retinol, in marginally nourished children: a cluster-randomized trial in rural Zambia. Am J Clin Nutr. 2016 Jul;104(1):181-90. doi: 10.3945/ajcn.116.132571. Epub 2016 May 11.
PubMed 27169838
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of β-carotene Biofortified Maize in Improving Vitamin A Status and Reducing the Prevalence of Vitamin A Deficiency Among Children in Rural Zambia
- ClinicalTrials.gov ID
- NCT01695148
- Acronym / sponsor ID
- JHU IRB 4150
- Conditions
- Vitamin A Deficiency, Low Serum Retinol
- Keywords
- beta-carotene biofortified maize, micronutrients, vitamin A, serum retinol, dark adaptation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,228 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Food and Nutrition Commission, Zambia, Tropical Diseases Research Centre, Zambia, HarvestPlus, Canadian International Development Agency, Zambia Agriculture Research Institute
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Sep 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 purpose of this cluster-randomized trial is to examine whether daily consumption of β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and improve the vitamin A status and among 4-8 year old children in rural Zambia.
Detailed description
Vitamin A deficiency is a major public health problem in Zambia, affecting approximately 40% of young children. We aim to conduct a cluster-randomised controlled trial in the Mkushi region of rural Zambia to test whether feeding children two daily meals containing β-carotene biofortified maize flour compared to regular white maize flour-based meals for six months can reduce the prevalence of vitamin A deficiency and improve the vitamin A status among 4-8 year old children. Five hundred children in each arm will receive 2 meals a day, 6 days a week for 6 months, after which changes in serum retinol concentrations will be compared. An additional arm of 250 children, enrolled from randomly sampled clusters, will not receive the maize flour intervention but concurrently followed in order to evaluate overall effects of the maize flour feeding scheme on measures of household food security.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| White Maize Flour | Active comparator | Dietary Supplement: White Maize FlourChildren will receive 2 meals a day (~200 g of white maize flour), 6 days a week for 6 months. |
| β-Carotene Biofortified Maize | Experimental | Dietary Supplement: β-Carotene Biofortified Maize FlourChildren will receive 2 meals a day (~200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months. |
| Non-Intervened | No intervention | –Children will receive no food for the duration of the study, but families in this group will receive an equivalent ration of food items at the end of the trial. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 4-8 years of age
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| β-Carotene Biofortified Maize Flour | Dietary supplement | β-Carotene Biofortified Maize |
| White Maize Flour | Dietary supplement | White Maize Flour |
Primary outcome
Increased Serum Retinol Concentration
Time frame: After 6 months of feeding
The investigators hypothesize a difference of 2.5 μg/dL or more in serum retinol among children receiving biofortified versus white maize flour-based meals. Serum retinol measures will be collected at baseline and at the end of 6 months and assessed by a High Performance Liquid Chromatography assay.
Decreased Prevalence of Vitamin A deficiency
Time frame: After 6 months of feeding
The investigators hypothesize a difference of 10% or more in the prevalence of vitamin A deficiency (i.e., serum retinol < 0.7 μmol/l) among children consuming biofortified versus white maize flour-based meals, assuming a baseline prevalence of 40%.
1 secondary outcome
Improved Dark Adaptation
Time frame: After 6 months of Feeding
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 7 Feb 2014.
- Background: PubMed 16988127Howe JA, Tanumihardjo SA. Carotenoid-biofortified maize maintains adequate vitamin a status in Mongolian gerbils. J Nutr. 2006 Oct;136(10):2562-7. doi: 10.1093/jn/136.10.2562.
- Background: PubMed 17032000Howe JA, Tanumihardjo SA. Evaluation of analytical methods for carotenoid extraction from biofortified maize (Zea mays sp.). J Agric Food Chem. 2006 Oct 18;54(21):7992-7. doi: 10.1021/jf062256f.
- Background: PubMed 18312712Davis C, Jing H, Howe JA, Rocheford T, Tanumihardjo SA. beta-Cryptoxanthin from supplements or carotenoid-enhanced maize maintains liver vitamin A in Mongolian gerbils ( Meriones unguiculatus) better than or equal to beta-carotene supplements. Br J Nutr. 2008 Oct;100(4):786-93. doi: 10.1017/S0007114508944123. Epub 2008 Mar 3.
- Background: PubMed 18616269Davis CR, Howe JA, Rocheford TR, Tanumihardjo SA. The xanthophyll composition of biofortified maize (Zea mays Sp.) does not influence the bioefficacy of provitamin a carotenoids in Mongolian gerbils (Meriones unguiculatus). J Agric Food Chem. 2008 Aug 13;56(15):6745-50. doi: 10.1021/jf800816q. Epub 2008 Jul 11.
- Background: PubMed 21715509Muzhingi T, Gadaga TH, Siwela AH, Grusak MA, Russell RM, Tang G. Yellow maize with high beta-carotene is an effective source of vitamin A in healthy Zimbabwean men. Am J Clin Nutr. 2011 Aug;94(2):510-9. doi: 10.3945/ajcn.110.006486. Epub 2011 Jun 29.
- Derived from this study: PubMed 29924320Healy K, Palmer AC, Barffour MA, Schulze KJ, Siamusantu W, Chileshe J, West KP Jr, Labrique AB. Nutritional Status Measures Are Correlated with Pupillary Responsiveness in Zambian Children. J Nutr. 2018 Jul 1;148(7):1160-1166. doi: 10.1093/jn/nxy069.
- Derived from this study: PubMed 29321687Palmer AC, Craft NE, Schulze KJ, Barffour M, Chileshe J, Siamusantu W, West KP Jr. Impact of biofortified maize consumption on serum carotenoid concentrations in Zambian children. Eur J Clin Nutr. 2018 Feb;72(2):301-303. doi: 10.1038/s41430-017-0054-1. Epub 2018 Jan 10.
- Derived from this study: PubMed 28701387Barffour MA, Schulze KJ, Coles CL, Chileshe J, Kalungwana N, Arguello M, Siamusantu W, Moss WJ, West KP Jr, Palmer AC. High Iron Stores in the Low Malaria Season Increase Malaria Risk in the High Transmission Season in a Prospective Cohort of Rural Zambian Children. J Nutr. 2017 Aug;147(8):1531-1536. doi: 10.3945/jn.117.250381. Epub 2017 Jul 12.
- Derived from this study: PubMed 27798345Palmer AC, Healy K, Barffour MA, Siamusantu W, Chileshe J, Schulze KJ, West KP Jr, Labrique AB. Provitamin A Carotenoid-Biofortified Maize Consumption Increases Pupillary Responsiveness among Zambian Children in a Randomized Controlled Trial. J Nutr. 2016 Dec;146(12):2551-2558. doi: 10.3945/jn.116.239202. Epub 2016 Oct 19.
- Derived from this study: PubMed 27169838Palmer AC, Siamusantu W, Chileshe J, Schulze KJ, Barffour M, Craft NE, Molobeka N, Kalungwana N, Arguello MA, Mitra M, Caswell B, Klemm RD, West KP Jr. Provitamin A-biofortified maize increases serum beta-carotene, but not retinol, in marginally nourished children: a cluster-randomized trial in rural Zambia. Am J Clin Nutr. 2016 Jul;104(1):181-90. doi: 10.3945/ajcn.116.132571. Epub 2016 May 11.
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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.
Amanda C Palmer, PhD study director
Johns Hopkins Bloomberg School of Public Health
Rolf Klemm, DrPH study director
Johns Hopkins Bloomberg School of Public Health
Kerry J Schulze, PhD study director
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing β-Carotene Biofortified Maize Flour and White Maize Flour in people with Vitamin A Deficiency and Low Serum Retinol, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Zambia.
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 0 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 7 Feb 2014. 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 Zambia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Increased Serum Retinol Concentration (time frame: After 6 months of feeding). 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 NCT01695148, which also lists 10 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 7 Feb 2014.