Vitamin D Deficiency Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Month to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Vitamin D sulfate levels in breastmilk | Samples will be assessed using a Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) assay on the Agilent 6490 tandem mass spectrometer instrument. | Baseline, Day 28 | |
Secondary | Vitamin D sulfate levels in infant saliva | Samples will first be assessed for activity using a general sulfatase activity assay, followed by a Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) assay on the Agilent 6490 tandem mass spectrometer instrument. | Baseline | |
Secondary | Vitamin D sulfate levels in infant digesta | Samples will first be assessed for activity using a general sulfatase activity assay, followed by a Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) assay on the Agilent 6490 tandem mass spectrometer instrument. | Baseline |
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