Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Bone Mineral Density (BMD) in HIP at 6 Months
研究概览
简要总结
Studies have shown that lactation is associated with a loss of bone density from four to seven percent at the spine and hip among women who lactate for six months. Decline in bone density with lactation occurs rapidly. Although bone density increases after weaning, there is controversy on whether or not it is completely restored. Epidemiological studies find no significant negative impact of lactation on bone mass or fractures, and in fact there is evidence that lactation has a positive effect on bone mass. We think that interventions that attenuate this physiologic loss of bone that is associated with lactation and accelerate restoration of bone mass after weaning may result in improved long term bone mass and diminished fracture risk.
详细描述
Adequate vitamin D stores are necessary for skeletal health. Vitamin D deficiency is pronounced in women of child bearing age as well as pregnant women in the United States. This study will provide important information about whether vitamin D supplementation may positively impact the normal physiologic loss of bone mass that is observed during lactation.
Recruitment will begin while subjects are pregnant in order to expedite entry into the study in the immediate post-partum period. If subjects are deemed eligible during pregnancy, contact information to include name, address, expected delivery date and two contact phone numbers will be obtained. Subjects will be contacted two weeks prior to expected delivery date and then again at expected delivery date. Subjects will be followed for a total of 18 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Fully lactating mothers age 18 and up
- •Within 1 month after delivery
- •Plan to breast feed for at least 6 months
排除标准
- •Known metabolic bone disease
- •Chronic renal insufficiency
- •Chronic corticosteroid use
- •Eating disorder
- •Estrogen containing hormonal contraception use
- •Daily use of >400IU Vitamin D supplementation
- •Delivery of Multiples
- •Delivery of a singleton with a birth weight of <2500 grams
- •Preterm delivery of baby
- •History of kidney stones
研究组 & 干预措施
Vitamin D
4000IU Vitamin D3 in tablet taken daily with multivitamin
干预措施: Vitamin D3 (Drug)
Multivitamin
Multivitamin with 400IU vitamin D tablet
干预措施: Multivitamin (Dietary Supplement)
结局指标
主要结局
Change in Bone Mineral Density (BMD) in HIP at 6 Months
时间窗: Change from Baseline to 6 months
次要结局
- Change in 25-hyroxyvitamin D Levels at 3 Months(Change from Baseline to 3 Months)
- Change in 25-hyroxyvitamin D Levels at 6 Months(Change from Baseline to 6 Months)
- Change in Bone Mineral Density (BMD) at HIP at 3 Months(Change from Baseline to 3 months)
- Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months(Change from Baseline to 3 Months)
- Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months(Change from Baseline to 6 Months)
研究者
Leigh Eck, MD
Assistant Professor
University of Kansas Medical Center