Vitamin D Sulfates in Breastmilk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Change in Vitamin D sulfate levels in breastmilk
研究概览
简要总结
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.
详细描述
Infants
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lactating Mothers
- •Inclusion Criteria:
- •Lactating mothers
- •≥2 weeks after delivery
- •No intentions of weaning during the study
排除标准
- •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
研究组 & 干预措施
Lactating women
Subjects identified as having delivered an infant and lactating will receive Vitamin D3 for 28 days.
干预措施: Vitamin D (Dietary Supplement)
Breastfeeding Infants
No intervention will be administered.
结局指标
主要结局
Change in Vitamin D sulfate levels in breastmilk
时间窗: Baseline, Day 28
Samples will be assessed using a Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) assay on the Agilent 6490 tandem mass spectrometer instrument.
次要结局
- Vitamin D sulfate levels in infant saliva(Baseline)
- Vitamin D sulfate levels in infant digesta(Baseline)
研究者
Thomas Thacher
Principal Investigator
Mayo Clinic