Calcium Absorption in Postmenopausal Thai Women
2014年11月12日 更新者：Cornell University
Calcium Bioavailability of Cassia Leaves in Post-Menopausal Women
Adequate calcium absorption is essential for reducing one's risk of developing osteoporosis.
However, postmenopausal Thai women consume diets which are habitually low in calcium due to lactose intolerance and dietary patterns which typically do not include milk-based products.
The primary goal of this study is to measure the fractional calcium absorption from milk and a commonly ingested green leafy vegetable (cassia) in postmenopausal Thai women with habitually low calcium intakes.
The secondary objective is to determine associations between calcium absorption and biomarkers which impact vitamin D status and bone metabolism.
研究概览
地位
完全的
详细说明
Postmenopausal Thai women (n=22) will be recruited from the community surrounding Bangkok and Nakhon Pathon, Thailand.
They will be invited to participate in an isotope study comparing the fractional calcium absorption from milk and cassia.
Upon arrival, a fasting blood sample will be drawn on the morning of the absorption study to analyze serum markers of vitamin D and bone metabolism (25-hydroxy vitamin D [25OHD], parathyroid hormone [PTH], and beta-crossLaps) and to determine their impact on calcium absorption.
Following this blood draw, women will receive a stable calcium isotope (42Ca) intravenously.
Then for breakfast and lunch respectively, the women will be randomly assigned to orally ingest a stable calcium isotope from either the milk (44Ca) or cassia (43Ca) test meals.
On day two, women will receive a breakfast, snack, and lunch meal.
Urine samples will be collected over the entire 28 hour period and the 24-hr urine collection will be used to measure urinary calcium concentration and to calculate fractional calcium absorption.
研究类型
观察性的
注册 (实际的)
22
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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New York
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Ithaca、New York、美国、14853
- Human Metabolic Research Unit
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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
53年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
取样方法
概率样本
研究人群
Post-menopausal Thai women
描述
Inclusion Criteria:
- Healthy
- At least 3 years postmenopausal
Exclusion Criteria:
- Diagnosed gastrointestinal or metabolic diseases known to interfere with calcium absorption and metabolism
- Women taking medications (including thiazide diuretics, hormonal replacement therapy, etc.) within two months prior to the study
- Women taking dietary supplements within two months prior to the study
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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Test meal ingestion
On the morning of the absorption study, fasted women received 2 mg of 42Ca intravenously (in 5 ml of isotonic saline) over 5 minutes before being randomly assigned to receive either the milk or cassia meal first for breakfast and the milk or cassia meal second for lunch.
The milk meal consisted of approximately 100 mg of fresh ultrahigh temperature (UHT) milk to which 2 mg of 44Ca was added and allowed to equilibrate for 12 h prior to ingestion and the cassia meal consisted of 142 g of cooked cassia to which 1 mg of 43Ca was extrinsically added.
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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 |
|---|---|---|
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Fractional calcium absorption
大体时间：24 hours after the ingestion of the second test meal
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Urine samples will be collected over s 28 hour period post-dosing with collection ending 24 hours after the ingestion of the second test meal.
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24 hours after the ingestion of the second test meal
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The concentration of 25-hydroxy vitamin D (25OHD) in serum
大体时间：Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
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A fasting 10 mL blood sample will be collected upon entry into the study and used for determining the concentration of 25OHD in serum.
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Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
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The concentration of parathyroid hormone (PTH) in serum
大体时间：Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
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A fasting 10 mL blood sample will be collected upon entry into the study and used for determining the concentration of PTH in serum.
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Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
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The concentration of beta-crossLaps in serum
大体时间：Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
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A fasting 10 mL blood sample will be collected upon entry into the study and used for determining the concentration of beta-crossLaps in serum.
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Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.
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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
- 首席研究员：Prapaisri P. Sirichakwal, PhD、Mahidol University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2007年7月1日
初级完成 (实际的)
2007年9月1日
研究完成 (实际的)
2007年9月1日
研究注册日期
首次提交
2014年11月10日
首先提交符合 QC 标准的
2014年11月12日
首次发布 (估计)
2014年11月14日
研究记录更新
最后更新发布 (估计)
2014年11月14日
上次提交的符合 QC 标准的更新
2014年11月12日
最后验证
2014年11月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB #: MU 2007-145
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.