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

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT01803659
• Collaborator: Helen Keller International (Other)
• Enrollment: 85
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 17.1

Study Details

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	Phase
Vitamin A Status	Dietary Supplement: b-carotene; Dietary Supplement: retinyl palmitate; Dietary Supplement: placebo	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2013
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of California, Davis	Davis	California	United States	95616

Sponsors and Collaborators

• University of California, Davis
• Helen Keller International

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT01803659
• Other Study ID Numbers: 6195-2012-01-00-HKI
• First Posted: Mar 4, 2013
• Last Update Posted: Jun 11, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by University of California, Davis: b-carotene; breastmilk; vitamin A
• Additional relevant MeSH terms: Vitamin A; Retinol palmitate; Carotenoids

Study Results

No Results Posted as of Jun 11, 2015