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

Vitamin A Status Clinical Trial

Official title:

Effect of Small Daily Doses of B-carotene or Vitamin A on Breast Milk Retinol Concentration in Lactating Filipino Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803659
• Other study ID #: 6195-2012-01-00-HKI
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: June 10, 2015
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: June 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardPhilippines: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin A Status

Intervention

Dietary Supplement:
• b-carotene

• retinyl palmitate

• placebo

Locations

Country	Name	City	State
United States	University of California, Davis	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Helen Keller International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 weeks	No
Secondary	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	3 weeks	No