Vitamin A Status
Conditions
Keywords
b-carotene, breastmilk, vitamin A
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.
Interventions
Sponsors
Helen Keller International
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed