Vitamin D Sulfates in Breastmilk

May 11, 2026 updated by: Thomas Thacher, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Lactating Mothers

Inclusion Criteria:

  • Lactating mothers
  • ≥2 weeks after delivery
  • No intentions of weaning during the study

Exclusion Criteria:

  • History of sarcoidosis
  • History of renal disease
  • Premature birth- <37 weeks
  • Taking daily supplement with ≥600 IU vitamin D in the past 30 days

Breastfeeding Infants

Inclusion Criteria:

  • Female and male infants
  • Exclusively breastfed

Exclusion Criteria:

  • No known gastrointestinal diseases that require medical treatment
  • Currently prescribed antibiotics or have taken antibiotics <2 weeks from collection

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lactating women
Subjects identified as having delivered an infant and lactating will receive Vitamin D3 for 28 days.
Dietary supplement: Vitamin D
Orally administered, daily dose of 5000 IU (125 mcg) Vitamin D3 for 28 days.
Other Names:
  • cholecalciferol
No Intervention: Breastfeeding Infants
No intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vitamin D sulfate levels in breastmilk
Time Frame: Baseline, Day 28
Samples will be assessed using a Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) assay on the Agilent 6490 tandem mass spectrometer instrument.
Baseline, Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D sulfate levels in infant saliva
Time Frame: Baseline
Samples will first be assessed for activity using a general sulfatase activity assay, followed by a Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) assay on the Agilent 6490 tandem mass spectrometer instrument.
Baseline
Vitamin D sulfate levels in infant digesta
Time Frame: Baseline
Samples will first be assessed for activity using a general sulfatase activity assay, followed by a Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) assay on the Agilent 6490 tandem mass spectrometer instrument.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Thomas Thatcher, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2023

Primary Completion (Actual)

May 5, 2026

Study Completion (Actual)

May 5, 2026

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-005324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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