Vitamin D Sulfates in Breastmilk

NCT06203041 | Active Not Recruiting

• 1 other identifier: 22-005324
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin D Deficiency; Breast Milk Collection

Outcome Measures

Primary Outcomes (1)

• Change in Vitamin D sulfate levels in breastmilk

  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 Outcomes (2)

• Vitamin D sulfate levels in infant saliva

  Baseline

• Vitamin D sulfate levels in infant digesta

  Baseline

Study Arms (2)

Lactating women

EXPERIMENTAL

Subjects identified as having delivered an infant and lactating will receive Vitamin D3 for 28 days.

Dietary Supplement: Vitamin D

Breastfeeding Infants

NO INTERVENTION

No intervention will be administered.

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

Also known as: cholecalciferol

Lactating women

Eligibility Criteria

• Age: 1 Month - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• Female and male infants
• Exclusively breastfed
• No known gastrointestinal diseases that require medical treatment
• Currently prescribed antibiotics or have taken antibiotics \<2 weeks from collection

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Vitamin D Deficiency; Breast Milk Expression

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Breast Feeding; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Thomas Thatcher, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: November 21, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)