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OpenTrials
Completed

NCT Number: NCT01803659

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

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.

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Key information

Conditions

Vitamin A Status

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Davis, California, 95616, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

b-carotene

Dietary Supplement

retinyl palmitate

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. breast milk retinol concentration

    Time frame: 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 outcomes

  1. plasma retinol concentration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Helen Keller International

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2013
Registry last updated
Jun 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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