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

Not Applicable

Completed

• Conditions: Vitamin A Status
• Interventions: Dietary Supplement: placebo; Dietary Supplement: retinyl palmitate; Dietary Supplement: b-carotene

• Registration Number: NCT01803659
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo (corn oil)	placebo	0 ug RAE/d as corn oil
retinyl palmitate	retinyl palmitate	600 ug retinol equivalent/d, 6 d/wk for 3 weeks
b-carotene	b-carotene	600 ug RAE/d as b-carotene, 6 d/wk for 3 weeks

Primary Outcome Measures

Name	Time	Method
breast milk retinol concentration	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

Name	Time	Method
plasma retinol concentration	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

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Davis, California, United States