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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804490
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
University of California, Davis
Newcastle University
HarvestPlus
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency Dietary Supplement: Conventional white maize Dietary Supplement: Provitamin A carotenoid biofortified maize Dietary Supplement: Preformed vitamin A fortified maize Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Study Start Date : March 2016
Actual Primary Completion Date : June 2, 2017
Actual Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: White maize
Conventional maize flour
 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
Experimental: Biofortified maize
Provitamin A carotenoid biofortified maize flour
 Dietary Supplement: 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
Active Comparator: Fortified maize
Retinyl palmitate fortified maize flour
 Dietary Supplement: 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


Outcome Measures
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Primary Outcome Measures :
  1. Infant vitamin A stores [ Time Frame: 90 days ]
    Total body vitamin A stores of infants measured by retinol isotope dilution


Secondary Outcome Measures :
  1. Maternal breast milk retinol [ Time Frame: 90 days ]
    Breast milk retinol concentrations of women measured by high performance liquid chromatography

  2. Maternal plasma retinol [ Time Frame: 90 days ]
    Plasma retinol concentrations of women measured by high performance liquid chromatography

  3. Maternal dark adaptation [ Time Frame: 90 days ]
    Pupillary responsiveness of women measured by portable field dark adaptometer


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804490


Locations
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Zambia
JHU Office
Mkushi, Central Province, Zambia
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
University of California, Davis
Newcastle University
HarvestPlus
Investigators
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Principal Investigator: Amanda C Palmer, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Marjorie Haskell, PhD University of California, Davis
Study Director: Rose Mwanza, MD Provincial Medical Office, Central Province, Zambia
More Information
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Publications:

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02804490    
Other Study ID Numbers: 2014H8314.JHU
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Night Blindness
Vitamin A Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamin A
Provitamins
 Carotenoids
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents