NCT06203041

Vitamin D Sulfates in Breastmilk

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 1 Month – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Vitamin D Deficiency
• Breast Milk Collection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D	Orally administered, daily dose of 5000 IU (125 mcg) Vitamin D3 for 28 days.

Timeline

• Start date: 2023-11-21
• Primary completion: 2026-07-01
• Completion: 2027-12-01
• First posted: 2024-01-12
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States