CompletedNot Applicable

Vitamin D Sulfates in Breastmilk

United States101 participantsStarted 2023-11-21

Plain-language 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.

Who can participate

Age range

1 Month – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Vitamin D sulfate levels in breastmilk

Timeframe: Baseline, Day 28

Trial details

NCT IDNCT06203041

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-05

View on ClinicalTrials.gov More Vitamin D Deficiency trials