Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP): Maternal Diet and Vitamin D Supplementation Effects on Preterm Infants, a Randomized Control Pilot Study.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Mothers With Elevated Calcium Concentrations at Month 3
研究概览
简要总结
The overall goal of this study is to assess maternal vitamin D status along with diet, and milk composition, and in turn, to evaluate if infant vitamin D status can be improved with increased maternal supplementation and diet education. The central hypothesis is that by maximizing maternal vitamin D status in breastfed, preterm infants (<35 weeks), there will be an increase infant 25(OH)D status at 1,2, and 3 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women with documentation of fully breastfeeding who present within one month of delivery, who are 18-45 years old and in good general health will be eligible for participation.
- •Infants <35 weeks corrected gestational age at birth
排除标准
- •NO DMI/DMII, HTN, or parathyroid disease IF thyroid issues, currently euthyroid
- •Multiple gestations
- •No liver disease
- •No major congenital abnormalities
- •No kidney disease
- •No inborn errors of metabolism
- •No parathyroid disease
- •No disorders of calcium metabolism
- •No antiepileptics
- •No steroids
- •No congenital heart disease
- •No severe illness at birth deemed incompatible with survival
研究组 & 干预措施
Group A
干预措施: High dose Cholecalciferol (Drug)
Group B
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Number of Mothers With Elevated Calcium Concentrations at Month 3
时间窗: 3 months post enrollment
Number of mothers with serum calcium \> 10.5 mg/dL
Number of Infants With Elevated Calcium Concentration at Month 1
时间窗: 1 month post enrollment
Number of infants with serum calcium \> 11.0 mg/dL
Number of Infants With Elevated Calcium Concentration at Month 2
时间窗: 2 months post enrollment
Number of infants with serum calcium \> 11.0 mg/dL
Number of Infants With Elevated Calcium Concentration at Month 3
时间窗: 3 months post enrollment
Number of infants with serum calcium \> 11.0 mg/dL
Number of Infants With Sufficient 25(OH)D Stores at 3 Months
时间窗: 3 months post enrollment
Number of infants with 25(OH)D levels \> 20 ng/mL
Number of Mothers With Sufficient 25(OH)D Stores at 3 Months
时间窗: 3 months post enrollment
Number of mothers with 25(OH)D levels \>20 ng/mL
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1
时间窗: 1 month post enrollment
Number of mothers with serum calcium \> 1.0 mmol/mmol
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2
时间窗: 2 months post enrollment
Number of mothers with urine calcium/creatinine ratio \> 1.0 mmol/mmol
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3
时间窗: 3 months post enrollment
Number of mothers with urine calcium/creatinine ratio \> 1.0 mmol/mmol
Number of Mothers With Elevated Calcium Concentrations at 1 Month
时间窗: 1 month post enrollment
Number of mothers with serum calcium \> 10.5 mg/dL
Number of Mothers With Elevated Calcium Concentrations at Month 2
时间窗: 2 months post enrollment
Number of mothers with serum calcium \> 10.5 mg/dL
次要结局
未报告次要终点
研究者
Raechel Irons
Neonatal-Perinatal Fellow
Medical University of South Carolina