Vitamin D Sulfates in Breastmilk

Status Recruiting

Clinical Trial Summary

Infants The purpose of this study is to measure breastmilk's vitamin D sulfate nutritional value in infant's saliva and digesta (gut). Breastfeeding Mothers The purpose of this study is to measure Vitamin D sulfates in freshly expressed breastmilk samples before and after 28 days of Vitamin D supplementation in lactating mothers.

Clinical Trial Description

Infants Sign the consent form to confirm participation: You will be asked to bring a soiled diaper from the morning of the study visit. You will meet with a study team member who will collect up to 6 swabs total: Up to 3 cheek/mouth swabs to collect saliva Up to 3 stool/anus/diaper swabs Lactating Mothers Sign the consent form to confirm participation: Visit 1 (Baseline) You will meet with a study team member complete some demographic information and gestational age of the baby and birthdate, next you will have a blood draw and express breast milk in a private location, the study team will collect up to 50 ml of freshly expressed breast milk for the research study, you will be asked to bring your personal breast pump and collection container to each research visit, or manually express milk, see options below. The study team member will schedule visit 2. The study will provide the vitamin D supplement that you will take daily for 28 days. Visit 2 (post intervention) Approximately 28 days later you will meet with a study team member, have a blood draw and express breast milk in a private location, the study team will collect up to 50 ml of freshly expressed breast milk for the research study, you will be asked to bring your personal breast pump and collection container to each research visit, or manually express milk, see options below. The study team member will ask for the container the Vitamin D supplement was in. You have 2 options: Option 1: Bring along your personal breast pump and collection container to each study visit. The study team member will collect up to 50 ml of freshly expressed breast milk for the study. Option 2: You do not bring along your personal breast pump and containers to each study visit, instead you will be asked to: Manually express your breast milk into a specimen collection cup at each study visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06203041
Study type	Interventional
Source	Mayo Clinic
Contact	Renee Weatherly
Phone	507-266-4680
Email	weatherly.renee@mayo.edu
Status	Recruiting
Phase	N/A
Start date	November 21, 2023
Completion date	December 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.