NCT02804490

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

June 15, 2016

Last Update Submit

August 16, 2017

Conditions

Vitamin A Deficiency

Outcome Measures

Primary Outcomes (1)

  • Infant vitamin A stores

    Total body vitamin A stores of infants measured by retinol isotope dilution

    90 days

Secondary Outcomes (3)

  • Maternal breast milk retinol

    90 days

  • Maternal plasma retinol

    90 days

  • Maternal dark adaptation

    90 days

Study Arms (3)

White maize

PLACEBO COMPARATOR

Conventional maize flour

Dietary Supplement: Conventional white maize

Biofortified maize

EXPERIMENTAL

Provitamin A carotenoid biofortified maize flour

Dietary Supplement: Provitamin A carotenoid biofortified maize

Fortified maize

ACTIVE COMPARATOR

Retinyl palmitate fortified maize flour

Dietary Supplement: Preformed vitamin A fortified maize

Interventions

Conventional white maizeDIETARY_SUPPLEMENT

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

White maize
Provitamin A carotenoid biofortified maizeDIETARY_SUPPLEMENT

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

Biofortified maize
Preformed vitamin A fortified maizeDIETARY_SUPPLEMENT

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

Fortified maize

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JHU Office

Mkushi, Central Province, Zambia

Location

Related Publications (7)

  • 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.

    PMID: 25411289BACKGROUND

  • 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: 27169838BACKGROUND

  • 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.

    PMID: 24158962BACKGROUND

  • 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.

    PMID: 26156587BACKGROUND

  • 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

  • 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.

    PMID: 20810977BACKGROUND

  • 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.

    PMID: 33693468DERIVED

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

    PRINCIPAL INVESTIGATOR

  • Marjorie Haskell, PhD

    University of California, Davis

    STUDY DIRECTOR

  • Rose Mwanza, MD

    Provincial Medical Office, Central Province, Zambia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

March 1, 2016

Primary Completion

June 2, 2017

Study Completion

June 2, 2017

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

ZA(1)