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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by University of California, Davis
Sponsor:
Collaborators:
Johns Hopkins University
Tropical Diseases Research Centre, Zambia
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01922713
First received: August 12, 2013
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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 Intervention
Vitamin A Deficiency
Other: white maize and corn oil capsule
Other: orange maize and corn oil capsule
Other: white maize and vitamin A capsule

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Effect of Daily Consumption of β-carotene Biofortified Maize on Milk Retinol Concentration in Lactating Zambian Women

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Breast milk retinol concentration [ Time Frame: After 3 weeks of intervention ] [ Designated as safety issue: No ]
    Breast milk retinol concentration will be measured before and after 3 wk of consumption of orange maize (6 d/wk)


Secondary Outcome Measures:
  • Breastmilk beta-carotene concentration [ Time Frame: After 3 wk of intervention ] [ Designated as safety issue: No ]
    Breastmilk beta-carotene concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)


Other Outcome Measures:
  • Plasma retinol concentration [ Time Frame: After 3 wk of intervention ] [ Designated as safety issue: No ]
    Plasma retinol concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)


Estimated Enrollment: 150
Study Start Date: September 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: white maize
white maize and a corn oil capsule
Other: white maize and corn oil capsule
~ 0 ug RAE/d
Experimental: orange maize
orange maize and a corn oil capsule
Other: orange maize and 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 vitamin A capsule
600 ug RAE/d
Other Name: retinyl palmitate capsule

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922713

Locations
Zambia
Center for Human Nutrition Not yet recruiting
Mkushi, Mkushi District, Zambia
Principal Investigator: Amanda C Palmer, PhD         
Sponsors and Collaborators
University of California, Davis
Johns Hopkins University
Tropical Diseases Research Centre, Zambia
Investigators
Principal Investigator: Marjorie Haskell, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01922713     History of Changes
Other Study ID Numbers: HP-8282
Study First Received: August 12, 2013
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board
Zambia: Institutional Review Board

Keywords provided by University of California, Davis:
biofortification
vitamin A
maize
beta-carotene
breastmilk
Zambia

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Carotenoids
Retinol palmitate
Vitamin A
Vitamins
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014