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

January 22, 2015 updated by: University of California, Davis

Effect of Daily Consumption of β-carotene Biofortified Maize on Milk Retinol Concentration in Lactating Zambian Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
    • Mkushi District
      • Mkushi, Mkushi District, Zambia
        • Center for Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • retinyl palmitate capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
After 3 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
After 3 wk of intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
After 3 wk of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Johns Hopkins University
Tropical Diseases Research Centre, Zambia

Investigators

  • Principal Investigator: Marjorie Haskell, PhD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-8282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin A Deficiency

Clinical Trials on white maize and a corn oil capsule

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe