Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status

Vitamin A Deficiency Clinical Trial

Official title:

Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804490
• Other study ID #: 2014H8314.JHU
• Status: Completed
• Phase: Phase 3
• First received: June 15, 2016
• Last updated: August 16, 2017
• Start date: March 2016
• Est. completion date: June 2, 2017

Study information

• Verified date: August 2017
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized control trial is to test the impact of provitamin A carotenoid biofortified maize meal consumption on maternal and infant vitamin A status.

Description:

Vitamin A deficiency remains a major public health problem in low and middle income countries. Approximately 50% of Zambian children are thought to be affected. This randomized control trial will test the efficacy of provitamin A carotenoid biofortified maize meal consumption as a strategy to improve vitamin A status among lactating Zambian mothers and their infants. The investigators will enroll up to 255 mother/infant pairs to a three-month study, during which they will receive one of the following three interventions: 1) conventional white maize, 2) provitamin A carotenoid biofortified orange maize, or 3) preformed vitamin A fortified white maize.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: June 2, 2017
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Singleton birth

• No birth defects

• Free from chronic health conditions

• Infant received 100,000 IU vitamin A at 6 months of age

• Currently breastfeeding

• Not pregnant at 9 months post partum

• Hemoglobin > 8.0 g/dL for women and > 7.0 g/dL for infants

Exclusion Criteria:

• Multiple birth

• Birth defects

• Any chronic health condition requiring regular medical visits

• Infant did not receive vitamin A capsule at 6 months of age

• No longer breastfeeding

• Pregnant

• Hemoglobin = 8.0 g/dL for women or = 7.0 g/dL for infants

Related Conditions & MeSH terms

• Night Blindness
• Vitamin A Deficiency

Intervention

Dietary Supplement:
• Conventional white maize
Women and their infants will receive 2 meals/day prepared with conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
• Provitamin A carotenoid biofortified maize
Women and their infants will receive 2 meals/day prepared with provitamin A carotenoid biofortified orange maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
• Preformed vitamin A fortified maize
Women and their infants will receive 2 meals/day prepared with preformed vitamin A fortified, conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks

Locations

Country	Name	City	State
Zambia	JHU Office	Mkushi	Central Province

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	HarvestPlus, Newcastle University, University of California, Davis

Country where clinical trial is conducted

Zambia, 

References & Publications (6)

Gannon B, Kaliwile C, Arscott SA, Schmaelzle S, Chileshe J, Kalungwana N, Mosonda M, Pixley K, Masi C, Tanumihardjo SA. Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial. Am J Clin Nutr. 2014 Dec;100(6):1541-50. doi: 10.3945/ajcn.114.087379. Epub 2014 Oct 8. — View Citation

Labrique AB, Palmer AC, Healy K, Mehra S, Sauer TC, West KP Jr, Sommer A. A novel device for assessing dark adaptation in field settings. BMC Ophthalmol. 2015 Jul 9;15:74. doi: 10.1186/s12886-015-0062-7. — View Citation

Li S, Nugroho A, Rocheford T, White WS. Vitamin A equivalence of the ß-carotene in ß-carotene-biofortified maize porridge consumed by women. Am J Clin Nutr. 2010 Nov;92(5):1105-12. doi: 10.3945/ajcn.2010.29802. Epub 2010 Sep 1. — View Citation

Muzhingi T, Gadaga TH, Siwela AH, Grusak MA, Russell RM, Tang G. Yellow maize with high ß-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. — View Citation

Oxley A, Berry P, Taylor GA, Cowell J, Hall MJ, Hesketh J, Lietz G, Boddy AV. An LC/MS/MS method for stable isotope dilution studies of ß-carotene bioavailability, bioconversion, and vitamin A status in humans. J Lipid Res. 2014 Feb;55(2):319-28. doi: 10.1194/jlr.D040204. Epub 2013 Oct 24. — View Citation

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 ß-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant vitamin A stores	Total body vitamin A stores of infants measured by retinol isotope dilution	90 days
Secondary	Maternal breast milk retinol	Breast milk retinol concentrations of women measured by high performance liquid chromatography	90 days
Secondary	Maternal plasma retinol	Plasma retinol concentrations of women measured by high performance liquid chromatography	90 days
Secondary	Maternal dark adaptation	Pupillary responsiveness of women measured by portable field dark adaptometer	90 days