NCT01695148

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,228

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

September 25, 2012

Last Update Submit

February 5, 2014

Conditions

Vitamin A DeficiencyLow Serum Retinol

Keywords

beta-carotene biofortified maizemicronutrientsvitamin Aserum retinoldark adaptation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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%.

    After 6 months of feeding

Secondary Outcomes (1)

  • Improved Dark Adaptation

    After 6 months of Feeding

Study Arms (3)

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.

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.

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.

Interventions

β-Carotene Biofortified Maize FlourDIETARY_SUPPLEMENT
β-Carotene Biofortified Maize
White Maize FlourDIETARY_SUPPLEMENT
White Maize Flour

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children 4-8 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JHU Office

Mkushi, Zambia

Location

Related Publications (10)

  • 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.

    PMID: 16988127BACKGROUND

  • Howe 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.

    PMID: 17032000BACKGROUND

  • Davis 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.

    PMID: 18312712BACKGROUND

  • Davis 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.

    PMID: 18616269BACKGROUND

  • Muzhingi 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.

    PMID: 21715509BACKGROUND

  • Healy 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.

    PMID: 29924320DERIVED

  • Palmer 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.

    PMID: 29321687DERIVED

  • Barffour 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.

    PMID: 28701387DERIVED

  • Palmer 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.

    PMID: 27798345DERIVED

  • Palmer 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.

    PMID: 27169838DERIVED

MeSH Terms

Conditions

Vitamin A Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Amanda C Palmer, PhD

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

  • Rolf Klemm, DrPH

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

  • Kerry J Schulze, PhD

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

  • Alain Labrique, PhD

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

  • Parul Christian, DrPH

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

  • Sucheta Mehra, MS

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

  • Lee Shu-Fune Wu, MS

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2012

First Posted

September 27, 2012

Study Start

August 1, 2012

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

ZA(1)