NCT01803659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 11, 2015

Status Verified

June 1, 2015

Enrollment Period

5 months

First QC Date

February 28, 2013

Last Update Submit

June 10, 2015

Conditions

Vitamin A Status

Keywords

b-carotenebreastmilkvitamin A

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • plasma retinol concentration

    3 weeks

Study Arms (3)

b-carotene

EXPERIMENTAL

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

Dietary Supplement: b-carotene

retinyl palmitate

ACTIVE COMPARATOR

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

Dietary Supplement: retinyl palmitate

placebo (corn oil)

PLACEBO COMPARATOR

0 ug RAE/d as corn oil

Dietary Supplement: placebo

Interventions

b-caroteneDIETARY_SUPPLEMENT
b-carotene
retinyl palmitateDIETARY_SUPPLEMENT
retinyl palmitate
placeboDIETARY_SUPPLEMENT
placebo (corn oil)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • lactating women breastfeeding a single infant 4-12 months of age

You may not qualify if:

  • chronic disease
  • breastfeeding more than one infant
  • severe anemia
  • signs or symptoms of vitamin A deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

MeSH Terms

Interventions

beta Caroteneretinol palmitate

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 4, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 11, 2015

Record last verified: 2015-06

Locations

US(1)