Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-11-21
2026-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Lactating women
Subjects identified as having delivered an infant and lactating will receive Vitamin D3 for 28 days.
Vitamin D
Orally administered, daily dose of 5000 IU (125 mcg) Vitamin D3 for 28 days.
Breastfeeding Infants
No intervention will be administered.
No interventions assigned to this group
Interventions
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Vitamin D
Orally administered, daily dose of 5000 IU (125 mcg) Vitamin D3 for 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥2 weeks after delivery
* No intentions of weaning during the study
* Female and male infants
* Exclusively breastfed
Exclusion Criteria
* History of renal disease
* Premature birth- \<37 weeks
* Taking daily supplement with ≥600 IU vitamin D in the past 30 days
Breastfeeding Infants
* No known gastrointestinal diseases that require medical treatment
* Currently prescribed antibiotics or have taken antibiotics \<2 weeks from collection
1 Month
60 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Thomas Thacher
Principal Investigator
Principal Investigators
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Thomas Thatcher, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-005324
Identifier Type: -
Identifier Source: org_study_id
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