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OpenTrials
Completed

NCT Number: NCT06203041

Vitamin D Sulfates in Breastmilk

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.

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Key information

Age range

1 month–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

Orally administered, daily dose of 5000 IU (125 mcg) Vitamin D3 for 28 days.

Other names: cholecalciferol

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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