Effect of Small Daily Doses of B-carotene on Breast Milk Retinol

June 10, 2015 updated by: University of California, Davis

Effect of Small Daily Doses of B-carotene or Vitamin A on Breast Milk Retinol Concentration in Lactating Filipino Women.

The purpose of this pilot study is to determine whether breast milk retinol concentration increases in response to daily supplementation with small amounts of vitamin A (~600 ug RAE/d), as either a b-carotene or retinyl palmitate, 6 d/week for 3 weeks. A secondary purpose is to evaluate sampling methods for collecting breast milk samples in a community setting. The results of this pilot study will allow us to determine whether milk retinol is a useful indicator for evaluating the impact of food-based interventions on the vitamin A status of lactating women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

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

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California, Davis

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:

  • lactating women breastfeeding a single infant 4-12 months of age

Exclusion Criteria:

  • chronic disease
  • breastfeeding more than one infant
  • severe anemia
  • 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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: b-carotene
600 ug RAE/d as b-carotene, 6 d/wk for 3 weeks
Dietary supplement: b-carotene
ACTIVE_COMPARATOR: retinyl palmitate
600 ug retinol equivalent/d, 6 d/wk for 3 weeks
Dietary supplement: retinyl palmitate
PLACEBO_COMPARATOR: placebo (corn oil)
0 ug RAE/d as corn oil
Dietary supplement: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breast milk retinol concentration
Time Frame: 3 weeks
breast milk retinol concentration is measured at baseline and after 3 weeks of supplementation with 600 ug RAE/d (as either b-carotene or retinyl palmitate) or 0 ug RAE/d
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma retinol concentration
Time Frame: 3 weeks
plasma retinol concentration is measured at baseline and after 3 weeks of supplementation with 600 ug RAE/d (as either b-carotene or retinyl palmitate) or 0 ug RAE/d
3 weeks

Collaborators and Investigators

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

Sponsor

University of California, Davis

Collaborators

Helen Keller International

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

January 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (ESTIMATE)

March 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6195-2012-01-00-HKI

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.

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