Completed

Breast Milk Retinol Concentration Improvement with B-carotene or Vitamin A in Lactating Filipino Women

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What is being tested

b-carotene

+ retinyl palmitate

+ placebo

Dietary Supplement
Who is being recruted

From 18 to 35 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorUniversity of California, Davis
Last updated: June 11, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

This study focuses on lactating Filipino women and explores the impact of small daily doses of B-carotene or Vitamin A on the concentration of retinol, a form of Vitamin A, in breast milk. The main goal is to understand if this supplementation can increase the retinol levels in breast milk. This research is important as it could potentially improve the vitamin A status of lactating women, which is crucial for both the mother's and infant's health. During this study, participants receive either B-carotene or retinyl palmitate, a type of Vitamin A, as a supplement six days a week for three weeks. The dosage is approximately 600 ug RAE per day. The study measures the concentration of retinol in breast milk at the beginning and after the three-week supplementation period. This helps to evaluate if the supplementation is effective in increasing the retinol levels. The study also assesses different methods for collecting breast milk samples in a community setting.

Principal SponsorUniversity of California, Davis
Last updated: June 11, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

85 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
lactating women breastfeeding a single infant 4-12 months of age

4 exclusion criteria prevent from participating
breastfeeding more than one infant

chronic disease

severe anemia

signs or symptoms of vitamin A deficiency

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Group III

Placebo
0 ug RAE/d as corn oil

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of California, Davis

Davis, United StatesOpen University of California, Davis in Google Maps
CompletedOne Study Center