RECRUITING
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Vitamin D Sulfates in Breastmilk
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
🗓️ Study Start (Actual) 21 November 2023
🗓️ Primary Completion (Estimated) December 2026
✅ Study Completion (Estimated) December 2026
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 1 Month to 60 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 January 2024
  • First Submitted that Met QC Criteria 2 January 2024
  • First Posted 12 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 February 2024
  • Last Update Posted 6 February 2024
  • Last Verified February 2024
I'm interested ...!!