Vitamin D Ancillary Study in 5 Populations of African Origin (VIDA)
Determinants and Consequences of Low Vitamin D in Populations of African Descent
研究概览
详细说明
Through its key role in bone mineral metabolism vitamin D deficiency was one of the first nutritional deficits linked to a clinical disease. A range of population and clinical research has now implicated less severe vitamin D deficiency as a potential risk factor for several chronic diseases [Melamed, et al. J Am Soc Nephrol 2009;20:2631-9; Michos et al. Future Cardiol, 2009;5:15-8; Reis et al. Diabetes Metab, 2005;31:318-25] and all-cause mortality [Melamed et al. Arch Intern Med, 2008;168:1629-37; Durazo-Arvizu et al. International Workshop on Statistical Modeling(IWSM);2010] is significantly increased at the low end of the 25(OH)D distribution among blacks and whites in the follow-up data from NHANES III. One out of 2 adults in the US has a 25(OH)D serum level < 30 ng/ml [Ginde et al. Arch Intern Med, 2009;169:626-32], currently considered the threshold for health-promoting levels [Howe et al. N Engl J Med, 2007;357:1981-2]. Light skin facilitates formation of 25(OH)D and consequently only 3% of US blacks have "optimal" levels, with very low levels (<10 ng/mL) found in 29% of blacks, compared to 5% of whites and10% of Mexican Americans [Ginde et al. Arch Intern Med, 2009;169:626-32]. Concern exists therefore that low serum levels of 25(OH)D may contribute to the disproportionately high risk for some chronic diseases in US blacks (eg, obesity, hypertension and CVD) [Pilz et al. Nat Rev Cardiol, 2009;6:621-30; Wang et al. Circulation, 2008;117:503-11]. At the present time the most convincing body of data on 25(OH)D and risk of chronic disease exists for obesity; the study proposed here will be conducted as an extension of a major international project on determinants of weight gain in Afro-origin populations.
25(OH)D has regulatory functions in several physiologic systems. Paradoxically, while US blacks have relatively lower serum 25(OH)D they have higher bone mineral density (BMD) and lower fracture rates, suggesting important variation in metabolic set points across populations [Aloia, Am J Clin Nutr, 2008;88:545S-550S]. However, it is not known if US blacks are at increased risk from the non-skeletal effects of low 25(OH)D. The overall health consequences of this shift in 25(OH)D levels and the threshold of "normal" for US blacks are thus unknown. The primary aim of this study is therefore to define the optimal level of 25(OH)D and the appropriate threshold for supplementation in the multi-ethnic US population. These data could have an important impact on public health recommendations regarding health-promoting levels of 25(OH)D.
Vitamin D levels in West Africans are similar to US whites, and much higher than in US blacks (see preliminary data). These cross-population contrasts represent one of the most significant known examples of a gene-environment interaction. By sampling Afro-origin populations across a range of latitudes, Ca++ intake, diet patterns, and lifestyles the investigators will model the determinants of 25(OH)D and related health effects. This research will incorporate 3 novel aspects. First, data on 25(OH)D will be standardized and a set of key determinants of 25(OH)D levels from 5 geographically separated populations of African descent will be available. Second, the study will generate precise covariate measures for obesity and other CV traits to test prospectively the association with 25(OH)D. Third, the investigators will have DXA measurements to examine 25(OH)D - PTH - bone density relationships and address a fundamental question about regulation of mineral metabolism and bone health. A major strength of this study will be state-of-the-art measurements of covariates for obesity, including doubly labeled water, activity monitoring, body composition and dietary intake. The role of 25(OH)D in obesity risk can therefore be evaluated with control for all of the key determinants of energy balance.
This study will utilize existing data and fasting samples from an ongoing NIH-funded study [Modeling the Epidemiologic Transition Study (METS; DK080763)]. METS began recruiting 2500 adults of African ancestry ages 25-45 from 5 countries (500 each from the US, Jamaica, Seychelles, South Africa, and Ghana) in October 2009. This study extends the follow-up period currently funded by METS to 6.2 years and uses a combined cohort-ecologic design to examine within-person and between-group associations.
Specific Aims:
- Measure serum 25(OH)D and intact parathyroid hormone (iPTH) levels in 500 adults from the 5 METS sites (total N=2,500) at baseline and determine associations with latitude, diet, physical activity, adiposity, blood pressure (BP), and biochemical risk factors for CVD (eg, insulin, glucose, adiponectin, leptin, cholesterol).
- Examine the association between baseline serum 25(OH)D and iPTH levels and changes in body composition and blood pressure over 6.2 years of follow-up.
- Repeat measurement of serum 25(OH)D and iPTH at third follow-up examination (approximately 3.5 years after baseline) and measure BMD using DXA in the available cohort.
研究类型
联系人和位置
学习地点
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Kumasi、加纳
- Kwame Nkrumah University of Science and Technology
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Cape Town、南非
- University of Cape Town
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Victoria、塞舌尔
- University Institute of Social and Preventive Medicine
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Kingston、牙买加
- University of the West Indies
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Illinois
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Maywood、Illinois、美国、60153
- Department of Public Health Sciences; Loyola University Chicago
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Ages 25-44
Exclusion Criteria:
- Pregnant women will be excluded
学习计划
研究是如何设计的?
设计细节
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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25-Hydroxyvitamin D
大体时间:Baseline
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Baseline
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Parathyroid Hormone (iPTH)
大体时间:Baseline
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Baseline
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Blood Pressure
大体时间:Baseline, 2.5 years
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Baseline, 2.5 years
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Body Composition
大体时间:Baseline, 2.5 years
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Body composition is estimated using bioelectrical impedance analysis (BIA) and race/sex specific equations.
However, all participants will have body composition also measured using DXA (Dual energy x-ray absorptiometry).
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Baseline, 2.5 years
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Dietary Intake
大体时间:Baseline, 2.5 years
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Each participant will complete at least two 24-hour recalls using the multiple pass method during each examination, one at the initial clinic visit and the second when the activity monitor is collected.
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Baseline, 2.5 years
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Physical Activity
大体时间:Baseline, 2.5 years, 4 years
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Accelerometer
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Baseline, 2.5 years, 4 years
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Bone Mineral Density
大体时间:2.5 years
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Dual energy x-ray absorptiometry (DXA) is a densitometry technique which provides a two-dimensional image of the bone being measured, to produce bone mineral density (BMD) values (mass of bone tissue per unit area).
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2.5 years
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次要结果测量
结果测量 |
大体时间 |
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Serum Calcium
大体时间:Baseline, 2.5 years
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Baseline, 2.5 years
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Serum Albumin
大体时间:Baseline, 2.5 years
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Baseline, 2.5 years
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Urinary Calcium
大体时间:Baseline, 2.5 years
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Baseline, 2.5 years
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合作者和调查者
合作者
调查人员
- 首席研究员:Ramon A Durazo-Arvizu, PhD、Loyola University Chicago
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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