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

This study is currently recruiting participants.
Verified February 2013 by University of California, Davis
Sponsor:
Collaborator:
Helen Keller International
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01803659
First received: February 28, 2013
Last updated: March 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Breast Milk Vitamin A
Dietary Supplement: b-carotene
Dietary Supplement: retinyl palmitate
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Small Daily Doses of B-carotene or Vitamin A on Breast Milk Retinol Concentration in Lactating Filipino 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: 3 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • plasma retinol concentration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 75
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803659

Locations
United States, California
University of California, Davis Recruiting
Davis, California, United States, 95616
Contact: Marjorie Haskell, PhD    530-752-1992      
Sponsors and Collaborators
University of California, Davis
Helen Keller International
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01803659     History of Changes
Other Study ID Numbers: 6195-2012-01-00-HKI
Study First Received: February 28, 2013
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board
Philippines: Institutional Review Board

Keywords provided by University of California, Davis:
b-carotene
breastmilk
vitamin A

Additional relevant MeSH terms:
Carotenoids
Retinol palmitate
Vitamin A
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014