Maternal Oral Vitamin D Supplementation Via Daily or Monthly Regimens and the Effect on Levels of Vitamin D in Human Milk and Infant Serum
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The number of days of detectable milk vitamin D concentrations
研究概览
简要总结
Adequate vitamin D is essential for proper infant growth and development. However, human milk is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is to assess the feasibility of providing adequate vitamin D to breastfed infants through maternal vitamin D supplementation. Forty non-pregnant, lactating women at least 18 years of age with exclusively breastfed infants between the ages of 1 and 6 months will be randomized to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a single dose. Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary calcium; maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28 of the study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.
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
- None
入排标准
- 年龄范围
- 1 Month 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently lactating mothers at least 18 years of age
- •Willing to continue exclusively breastfeeding their infant throughout the study interval
- •The infant is 1-6 months of age at the beginning of the study
- •Willing and able to participate in all aspects of the study
- •Mother and infant are in good health, as determined by the study investigator
- •Have been provided with, understand, and have signed the informed consent for themselves and their child.
排除标准
- •Have recently travelled (within the preceding 30 days) or plan to travel south of 35 degrees north latitude during the study interval
- •Have recently or plan to engage in indoor tanning
- •Are currently taking medications that affect vitamin D metabolism, like steroids, anticonvulsants, or barbiturates
- •Are nursing multiple infants (e.g. twins)
- •Are taking greater than the daily recommended intake of 1000 mg elemental calcium as calcium supplements
- •Are taking greater than the standard daily dose of 400 IU of vitamin D found in prenatal vitamins
- •Infant weight below 1.67 kg
- •Mothers with baseline 25(OH)D levels >70 ng/ml, and/or infants with baseline 25(OH)D levels >70 ng/ml
- •History of kidney stones
研究组 & 干预措施
Vitamin D 5000 units daily
Vitamin D3 5000 IU daily given orally for 28 days
干预措施: Vitamin D3 (Dietary Supplement)
Vitamin D 150,000 units once
Single dose of vitamin D3 150,000 IU given orally once
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
The number of days of detectable milk vitamin D concentrations
时间窗: 28 days
To compare the number of days of detectable milk vitamin D concentrations and incremental area under the curve between two dosing regimens of oral cholecalciferol in lactating mothers.
次要结局
- Infant serum 25(OH)D concentration(28 days)