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Effect of Daily Consumption of Orange Maize on Breast Milk Retinol in Lactating Zambian Women

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: NCT01922713
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : January 26, 2015
Sponsor:
Collaborators:
Johns Hopkins University
Tropical Diseases Research Centre, Zambia
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief Summary:
The purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating Zambian women.

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency Other: white maize and a corn oil capsule Other: orange maize and a corn oil capsule Other: white maize and a vitamin A capsule Not Applicable

Detailed Description:
Lactating women were randomly assigned to one of three intervention groups to receive 6d/wk for 3 wk either 1) provitamin A biofortified orange maize and a corn oil capsule, 2) white maize and a vitamin A capsule, or 3) white maize and a corn oil capsule. The 'orange maize' and 'vitamin A' groups received ~600 ug RAE/d as provitamin A biofortified maize or retinyl palmitate, respectively. The 'white maize' group was a negative control group that did not receive any supplemental vitamin A.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Effect of Daily Consumption of β-carotene Biofortified Maize on Milk Retinol Concentration in Lactating Zambian Women
Study Start Date : October 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

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
white maize and a corn oil capsule
 Other: white maize and a corn oil capsule
~ 0 ug RAE/d
Experimental: orange maize
orange maize and a corn oil capsule
 Other: orange maize and a corn oil capsule
~600 ug RAE/d
Other Name: beta-carotene biofortified maize
Active Comparator: vitamin A
white maize and a vitamin A capsule
 Other: white maize and a vitamin A capsule
600 ug RAE/d
Other Name: retinyl palmitate capsule


Outcome Measures
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Primary Outcome Measures :
  1. Breast milk retinol concentration [ Time Frame: After 3 weeks of intervention ]
    Breast milk retinol concentration will be measured before and after 3 wk of consumption of orange maize (6 d/wk)


Secondary Outcome Measures :
  1. Breastmilk beta-carotene concentration [ Time Frame: After 3 wk of intervention ]
    Breastmilk beta-carotene concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)


Other Outcome Measures:
  1. Plasma retinol concentration [ Time Frame: After 3 wk of intervention ]
    Plasma retinol concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Apparently healthy lactating women 18-35 years of age
  • who are breastfeeding a single infant, 4-12 mo of age.

Exclusion Criteria:

  • Pregnancy,
  • Chronic disease,
  • Hb concentration <90 g/L,
  • Signs or symptoms of vitamin A deficiency
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): NCT01922713


Locations
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Zambia
Center for Human Nutrition
Mkushi, Mkushi District, Zambia
Sponsors and Collaborators
University of California, Davis
Johns Hopkins University
Tropical Diseases Research Centre, Zambia
Investigators
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Principal Investigator: Marjorie Haskell, PhD University of California, Davis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01922713    
Other Study ID Numbers: HP-8282
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015
Keywords provided by University of California, Davis:
biofortification
vitamin A
maize
 beta-carotene
breastmilk
Zambia
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
Beta Carotene
Retinol palmitate
 Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Provitamins