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临床试验/NCT01971411
NCT01971411已完成不适用

Vitamin D Deficiency in Elderly African American Women in Central Texas

McLennan County Medical Education and Research Foundation1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Bone mineral density

研究概览

简要总结

In order to make bone health a reality for older adults, we need to consider the prevalence of Vitamin D deficiency in relation to environment latitude as well as vitamin D supplementation. Darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of Vitamin D. The aim of this project is to document vitamin D deficiency in elderly African American women living in a southern latitude.

详细描述

Summary: Since darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of Vitamin D, we hypothesize that: 1) the usual sun exposure in the southern United States may not be sufficient to maintain adequate vitamin D levels in elderly African American women, 2) recommended supplementation of Vitamin D 400 IU/d may not be adequate to prevent Vitamin D deficiency which in turn could lead to calcium deficiency and possibly sub-clinical hyperparathyroidism.

This study will enroll 60 African American women age 65 or older who do not have renal, hepatic or gastrointestinal disorders that could affect Vitamin D and calcium absorption and metabolism. Patients will have two scheduled office visits. Demographic data will be collected with attention to dietary intake of calcium and vitamin D, and the patient's customary degree of sun exposure. Ca, 25-hydroxyvitamin D, PTH and serum CTX (a bone resorption marker) are measured on enrollment day and repeated 6 weeks later. All patients not already taking 1000 mg Calcium with 400 IU of Vitamin D orally daily were given samples of this supplement to last for 6 weeks without making any change in diet or sun exposure recommendations. The study period will extend April to June - a time when there should be ample sunlight but it is not so hot as to stop the elderly from going outdoors. Statistical analysis will be performed as to the effect(s) of ethnic background, age, diet, and intensity of sun exposure as related to Ca, 25-hydroxyvitamin D, PTH and serum CTX.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 70 or older woman
  • African American ethnicity
  • Non-institutionalized

排除标准

  • De-compensated hepatic insufficiency
  • Renal insufficiency with GFR estimated to be < 30 ml/min
  • Gastrointestinal disorders that might affect absorption such as known malabsorption, celiac sprue, short gut or blind loop syndrome.
  • Institutionalized

研究组 & 干预措施

Community dwelling elderly black females

干预措施: Calcium 500mg with 200 IU Vitamin D - 2 tablets daily (Drug)

Community dwelling elderly black females

干预措施: Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH (Procedure)

Community dwelling elderly black females

干预措施: Usual sun exposure documentation (Behavioral)

Community dwelling elderly black females

干预措施: Dietary intake of calcium, vitamin D, magnesium (Behavioral)

结局指标

主要结局

Bone mineral density

时间窗: 6 week period in 2007

次要结局

未报告次要终点

研究者

发起方
McLennan County Medical Education and Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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