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

University of California, Davis85 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Vitamin A Status

Interventions

b-caroteneDIETARY_SUPPLEMENT

retinyl palmitateDIETARY_SUPPLEMENT

placeboDIETARY_SUPPLEMENT

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of California, Davis

Davis, California, United States

Outcomes

Primary Outcomes

breast milk retinol concentration

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

Time frame: 3 weeks

Secondary Outcomes

plasma retinol concentration

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

Time frame: 3 weeks

Data from ClinicalTrials.gov

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