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

University of California (UC) Davis

Status: Completed

Conditions: Vitamin A Status

Treatments: Dietary Supplement: retinyl palmitate; Dietary Supplement: b-carotene; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01803659

6195-2012-01-00-HKI

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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85 participants in 3 patient groups, including a placebo group

b-carotene

Experimental group

Description:

600 ug RAE/d as b-carotene, 6 d/wk for 3 weeks

Treatment:

Dietary Supplement: b-carotene

retinyl palmitate

Active Comparator group

Description:

600 ug retinol equivalent/d, 6 d/wk for 3 weeks

Treatment:

Dietary Supplement: retinyl palmitate

placebo (corn oil)

Placebo Comparator group

Description:

0 ug RAE/d as corn oil

Treatment:

Dietary Supplement: placebo