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Vitamin D Ancillary Study in 5 Populations of African Origin (VIDA)

2017年8月28日 更新者:Ramon Durazo、Loyola University

Determinants and Consequences of Low Vitamin D in Populations of African Descent

The availability of data on plasma 25-Hydroxyvitamin D (25(OH)D) concentrations in the last two rounds of the National Health and Nutrition Examination Survey (NHANES) has generated a high level of interest in the consequences of 25(OH)D deficiency and in particular its potential impact on black Americans. Fundamental new questions about the biology of vitamin D have now come to the fore. Are low 25(OH)D-intact parathyroid hormone (iPTH) levels a physiologic "abnormality" in African Americans or does the 25(OH)D-iPTH system have sufficient plasticity to adapt to low sunlight exposure? Could the low 25(OH)D levels which result from the "gene- environment discordance" observed in dark skinned populations in the US be a risk factor for metabolic disorders? Ultimately, the public health community and regulatory bodies must offer recommendations for optimal levels and supplementation. The investigators propose to utilize cohorts from an ongoing NIH-funded study designed to identify determinants of weight change and cardiovascular disease risk in five Afro-origin populations [Modeling the Epidemiologic Transition Study (METS)] to examine these questions. The five METS countries include Ghana, Seychelles, South Africa, Jamaica and the US; the five populations differ greatly in terms of sun exposure and dietary intakes. In addition to the extensive energy expenditure, dietary intake and obesity-related metabolic markers being measured in METS, the investigators propose to assess plasma 25(OH)D, iPTH, serum and urinary calcium, plasma markers of bone resorption and formation, and quantitative ultrasound of the calcaneus. The associations of adiposity, weight change, cardiovascular disease (CVD) risk factors such as blood pressure and insulin, and bone strength with 25(OH)D and iPTH will be assessed. The proposed study will provide a comprehensive assessment of the distribution and determinants of 25(OH)D-iPTH and related physiologic measures across a wide range of latitude and lifestyles. These data should contribute substantially to the understanding of the "normal" range within which these hormones function and their significance in Afro- origin populations.

研究概览

地位

撤销

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:

  1. 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).
  2. 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.
  3. 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

观察性的

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

      • Kumasi、加纳
        • Kwame Nkrumah University of Science and Technology
      • Cape Town、南非
        • University of Cape Town
      • Victoria、塞舌尔
        • University Institute of Social and Preventive Medicine
      • Kingston、牙买加
        • University of the West Indies
    • Illinois
      • Maywood、Illinois、美国、60153
        • Department of Public Health Sciences; Loyola University Chicago

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

25年 至 44年 (成人)

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

A community-based probability sampling strategy is being used to recruit 500 adults, ages 25-44, from metropolitan Chicago, Spanish Town Jamaica, rural Ghana near Kumasi, Cape Town South Africa, and the Seychelles in the Indian Ocean

描述

Inclusion Criteria:

  • Ages 25-44

Exclusion Criteria:

  • Pregnant women will be excluded

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

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
25-Hydroxyvitamin D
大体时间:Baseline
Baseline
Parathyroid Hormone (iPTH)
大体时间:Baseline
Baseline
Blood Pressure
大体时间:Baseline, 2.5 years
Baseline, 2.5 years
Body Composition
大体时间:Baseline, 2.5 years
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).
Baseline, 2.5 years
Dietary Intake
大体时间:Baseline, 2.5 years
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.
Baseline, 2.5 years
Physical Activity
大体时间:Baseline, 2.5 years, 4 years
Accelerometer
Baseline, 2.5 years, 4 years
Bone Mineral Density
大体时间:2.5 years
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).
2.5 years

次要结果测量

结果测量
大体时间
Serum Calcium
大体时间:Baseline, 2.5 years
Baseline, 2.5 years
Serum Albumin
大体时间:Baseline, 2.5 years
Baseline, 2.5 years
Urinary Calcium
大体时间:Baseline, 2.5 years
Baseline, 2.5 years

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。

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 (预期的)

2011年9月1日

初级完成 (实际的)

2011年9月1日

研究完成 (实际的)

2011年9月1日

研究注册日期

首次提交

2014年4月4日

首先提交符合 QC 标准的

2014年4月10日

首次发布 (估计)

2014年4月11日

研究记录更新

最后更新发布 (实际的)

2017年8月30日

上次提交的符合 QC 标准的更新

2017年8月28日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 202538
  • 1R01DK090360-01A1 (美国 NIH 拨款/合同)

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