Study of Breastmilk With Vitamin D-Sulfates

Overview

About this study

The purpose of this study is to measure a naturally modified form of vitamin D metabolites, known as vitamin D sulfates, in freshly expressed breastmilk samples and identify correlations with serum vitamin D status. Knowledge obtained from these measurements could suggest alternative approaches to improving vitamin D intake for infants.

Obejctive 2- Test sulfatase activity in infant saliva and digesta by non- invasive swabs to determine nutritional value of visitamin D sulfates for the infant.

Objective 3- Measurement of Vitamin D- Sulfate and 25- Hydroxyvitamin D- Sulfate in women who may be at risk for Vitamin D deficiency. Lactating women >3 weeks after delivery

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/29/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Thomas Thacher, M.D.	Open for enrollment	Contact information: Renee Weatherly (507) 266-4680 weatherly.renee@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Thomas Thacher, M.D.

Open for enrollment

Contact information:

Renee Weatherly

(507) 266-4680

weatherly.renee@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials