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

NCT ID: NCT01803659

Last Updated: 2015-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Vitamin A Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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b-carotene

600 ug RAE/d as b-carotene, 6 d/wk for 3 weeks

Group Type EXPERIMENTAL

b-carotene

Intervention Type DIETARY_SUPPLEMENT

retinyl palmitate

600 ug retinol equivalent/d, 6 d/wk for 3 weeks

Group Type ACTIVE_COMPARATOR

retinyl palmitate

Intervention Type DIETARY_SUPPLEMENT

placebo (corn oil)

0 ug RAE/d as corn oil

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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b-carotene

Intervention Type DIETARY_SUPPLEMENT

retinyl palmitate

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Helen Keller International

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, Davis

Davis, California, United States

Site Status

Countries

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United States

Other Identifiers

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6195-2012-01-00-HKI

Identifier Type: -

Identifier Source: org_study_id

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