Clinical trial NCT02804490: Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Official title: Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitamin A Deficiency
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: Newcastle University
name: HarvestPlus
First posted: 2016-06-17
Enrollment: 255
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant vitamin A stores
timeFrame: 90 days
Secondary outcomes:
measure: Maternal breast milk retinol
timeFrame: 90 days
measure: Maternal plasma retinol
timeFrame: 90 days
measure: Maternal dark adaptation
timeFrame: 90 days
Other outcomes:
Locations:
city: Mkushi
country: Zambia
facility: JHU Office
state: Central Province
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Amanda C Palmer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Marjorie Haskell, PhD
role: STUDY_DIRECTOR
affiliation: Provincial Medical Office, Central Province, Zambia
name: Rose Mwanza, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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 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.
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 beta-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.
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.
citation: 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.
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.
citation: Palmer AC, Jobarteh ML, Chipili M, Greene MD, Oxley A, Lietz G, Mwanza R, Haskell MJ. Biofortified and fortified maize consumption reduces prevalence of low milk retinol, but does not increase vitamin A stores of breastfeeding Zambian infants with adequate reserves: a randomized controlled trial. Am J Clin Nutr. 2021 May 8;113(5):1209-1220. doi: 10.1093/ajcn/nqaa429.