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

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ClinicalTrials.gov Identifier: NCT01803659
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : June 11, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Vitamin A Status Dietary Supplement: b-carotene Dietary Supplement: retinyl palmitate Dietary Supplement: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : January 2013
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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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:

  • 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

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): NCT01803659


Locations
United States, California
University of California, Davis
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Helen Keller International
More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01803659     History of Changes
Other Study ID Numbers: 6195-2012-01-00-HKI
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015

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

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