Vitamin D Status and the Adequacy of Vitamin D Intake in Early Preterm Infants
2013年4月17日 更新者:Dr. Henry Akinbi、Children's Hospital Medical Center, Cincinnati
Adequacy of Vitamin D Intake and Vitamin D Status in Early Preterm Infants
Vitamin D is an essential nutrient.
Deficiency of vitamin D is widespread.
The prevalence of vitamin D deficiency in early preterm infants is unknown.
The American Academy of Pediatrics recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D. This study assesses vitamin D status at birth and during hospital stay in infants delivered delivered at earlier than or at 32 weeks gestation.
We also assess the adequacy of intake relative to the target set by the American Academy of Pediatrics for children.
研究概览
地位
完全的
条件
详细说明
Vitamin D is important for bone health.
Deficiency of vitamin D is widespread and is associated with a variety of diseases.
Preterm infants are susceptible osteopenia of prematurity (OP).
Vitamin D deficiency may contribute to OP.
The American Academy of Pediatrics (AAP) recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D. Whether this level of intake or target serum concentration are achieved in early preterm infants is unknown.
We hypothesize that because early preterm infants are sequestered in the Newborn Intensive Care Units for an extended period of time, they will be deficient in vitamin D and that the current nutritional intake may not be adequate in meeting the AAP recommendation.
We assessed the concentration of serum 25-hydroxyvitamin-D in parturient mothers and in their newborns if they were less than 32 week gestation.
We monitored vitamin D intake during hospitalization in the Newborn Intensive Care Unit and serum 25-hydroxyvitamin-D at discharge.
研究类型
观察性的
注册 (实际的)
120
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Ohio
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Cincinnati、Ohio、美国、45229
- University of Cincinnati Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1天 至 1周 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
All infants born at or less than 32 weeks postmenstrual age admitted to the Newborn Intensive Care Unit at University of Cincinnati Medical Center were eligible.
Intake of vitamin D and serum 25-hydroxyvitamin-D concentrations were assessed during stay in the Newborn Intensive Care Unit.
描述
Inclusion Criteria:
- All neonates delivered at or less than 32 weeks gestation were eligible.
Exclusion Criteria:
- Infants with lethal congenital malformation
- Infants that were not expected to survive to discharge
- Infants delivered from multiple gestation
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Preterm infants born at or less than 32 weeks gestation
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Serum 25-hydroxyvitamin-D concentration at the time of birth and at discharge from the hospital.
大体时间:6 weeks
|
This is a longitudinal study that assessed vitamin D status at birth in infants as well as in their mothers.
Daily intake of vitamin D was analyzed.
The serum concentration of 25-hydroxyvitamin-D at discharge was assessed.
We correlated maternal vitamin D with infants' vitamin D concentrations at birth.
We also correlated vitamin D concentration at birth with the concentration at discharge.
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6 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Henry T Akinbi, M.D.、Children's Hospital Medical Center, Cincinnati
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年10月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2012年6月1日
研究注册日期
首次提交
2013年2月13日
首先提交符合 QC 标准的
2013年2月13日
首次发布 (估计)
2013年2月15日
研究记录更新
最后更新发布 (估计)
2013年4月19日
上次提交的符合 QC 标准的更新
2013年4月17日
最后验证
2013年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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