Measuring Vitamin D Sulfates in Breastmilk
Vitamin D Sulfates in Breastmilk
This study is testing how taking vitamin D supplements affects the levels of vitamin D in breastmilk and how it impacts the health of breastfeeding mothers and their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Month to 60 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06203041 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the nutritional value of vitamin D sulfates in breastmilk by collecting samples from lactating mothers before and after a 28-day vitamin D supplementation period. Infants will also participate by providing saliva and stool samples to evaluate the vitamin D sulfate levels in their systems. The study involves two visits for mothers, where they will express breast milk and undergo blood draws, while infants will provide swabs from their mouths and diapers. The goal is to understand the impact of maternal vitamin D supplementation on breastmilk and infant health.
Who should consider this trial
Good fit: Ideal candidates include lactating mothers who are at least two weeks postpartum and exclusively breastfeeding their infants.
Not a fit: Patients who have a history of sarcoidosis, renal disease, or are taking high doses of vitamin D supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of vitamin D's role in infant nutrition and potentially improve guidelines for maternal supplementation.
How similar studies have performed: While there is ongoing research into vitamin D supplementation, this specific approach to measuring its impact in breastmilk and infant health is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Thatcher, MD — Mayo Clinic
- Study coordinator: Renee Weatherly
- Email: weatherly.renee@mayo.edu
- Phone: 507-266-4680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.