VITamin D and OmegA-3 TriaL (VITAL): Interrelationship of Vitamin D and Vitamin K on Bone
维生素 D 和 OmegA-3 TriaL (VITAL):维生素 D 和维生素 K 对骨骼的相互关系
基本信息
- 批准号:10219961
- 负责人:
- 金额:$ 65.68万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2012
- 资助国家:美国
- 起止时间:2012-08-01 至 2023-07-31
- 项目状态:已结题
- 来源:
- 关键词:AffectAfrican AmericanAmericanAncillary StudyArchitectureAttenuatedBiological MarkersBlood specimenBody mass indexBone DensityBone DiseasesBone MatrixBone structureCalciumCardiovascular DiseasesCholecalciferolCollectionCreatinineDepositionDeteriorationDoseDual-Energy X-Ray AbsorptiometryElderlyEthnic OriginFastingFemoral FracturesFish OilsFractureGoalsGrantGuidelinesHigh PrevalenceHip FracturesIntakeIntestinesKidneyKidney CalculiKnowledgeMalignant NeoplasmsMeasuresMedical RecordsNephrolithiasisNorwayObservational StudyOmega-3 Fatty AcidsOsteocalcinOsteoporosisOutcomePTH geneParentsParticipantPeripheralPlacebosPlayPrimary Cancer PreventionProductionProteinsPublic HealthQuestionnairesRaceRandomizedRandomized Controlled TrialsRecommendationResourcesRiskRisk FactorsRodent ModelRoleSerumSpottingsStructureSupplementationTestingTissuesToxic effectTrabecular Bone ScoreUnited States National Institutes of HealthUrineVitamin DVitamin D DeficiencyVitamin D supplementationVitamin KVitamin K 1WomanX-Ray Computed Tomographyadjudicateadjudicationage groupagedbonebone healthbone lossbone massbone turnovercalcificationcalcium absorptioncalcium excretioncarboxylatecarboxylationclinical carecohortcostcost efficientdesigndietaryfollow-upfracture riskfragility fracturehigh riskimaging studyimprovedinnovationinsightmatrix Gla proteinmenolder menolder womenprotein Kprotein functionradiological imagingrecruitsexsoft tissuesystematic review
项目摘要
ABSTRACT
Osteoporosis is the most common bone disease; 53.6 million Americans have a reduced bone mass, which
increases their risk of fragility fractures. In addition to the high prevalence of vitamin D deficiency, recent
studies show that approximately 60% of older men and 40% of older women have inadequate vitamin K
intakes. Growing evidence indicates that there are important interrelationships between vitamin D and vitamin
K on bone. Vitamin D increases intestinal calcium absorption and stimulates production of two proteins,
osteocalcin and matrix Gla protein. Vitamin K plays an essential role in activating these proteins so that
osteocalcin incorporates calcium in bone and matrix Gla protein inhibits calcification in soft tissues, including
the kidney. Both vitamins D and K are important for optimal function of these proteins. Although vitamin D
supplements are widely used to improve bone health, trials of supplemental vitamin D alone in reducing
fractures showed inconsistent results. Emerging evidence indicates that supplemental D in the context of low
vitamin K status is less effective on bone health measures. Therefore, low vitamin K status may account for
some of the inconsistencies of trials testing vitamin D and bone health and may contribute to toxicities
attributed to high-dose vitamin D such as kidney stones. No previous randomized controlled trials have been
adequately powered to test effects of vitamin K status on fracture risk or the interaction of vitamin K status with
high-dose, supplemental vitamin D on bone. To fill knowledge gaps, we propose an innovative, ancillary study
to the large, NIH-sponsored, VITamin D and OmegA-3 TriaL (VITAL). VITAL is testing effects of supplemental
vitamin D3 (cholecalciferol, 2000 IU/d), and/or omega-3 fatty acids (fish oil, 1 g/d) in the primary prevention of
cancer and cardiovascular disease in 25,871 U.S. men (aged ≥50) and women (aged ≥55), including 5,106
African Americans. In this competitive renewal application of “VITAL: Effects on Bone Structure and
Architecture,” we will determine whether low vitamin K status, assessed by 3 sensitive biomarkers, modifies
effects of supplemental vitamin D on fractures, bone mineral density (BMD) and structure, and secondarily on
increases in urine calcium excretion, a risk factor for low BMD and kidney stones. During the first cycle of this
grant, we surpassed recruitment goals and collected baseline and 2-yr post-randomization imaging studies for
bone density, structure and architecture that will be used in the proposed studies (n=771). In addition, other
key VITAL resources will be leveraged including: 16,953 baseline and 6,000 follow-up blood samples;
measures of vitamin D, calcium, creatinine and parathyroid hormone; and adjudicated fractures and kidney
stones. This proposal provides a unique opportunity to clarify in the largest study of supplemental vitamin D,
the interdependencies of vitamins D and K and their roles on fractures, bone health measures, and urine
calcium excretion. Findings from the proposed ancillary study will be critical to the interpretation of on-going
vitamin D trials and provide new insights to advance clinical care and public health recommendations.
摘要
骨质疏松症是最常见的骨骼疾病; 5360万美国人骨量减少,
增加了他们脆弱性骨折的风险。除了维生素D缺乏症的高患病率外,
研究表明,大约60%的老年男性和40%的老年女性缺乏维生素K。
摄入量越来越多的证据表明,维生素D和维生素C之间存在重要的相互关系。
K在骨头上。维生素D增加肠道钙吸收,刺激两种蛋白质的产生,
骨钙素和基质Gla蛋白。维生素K在激活这些蛋白质中起着重要作用,
骨钙素将钙掺入骨中,基质Gla蛋白抑制软组织中的钙化,包括
肾脏维生素D和K对这些蛋白质的最佳功能都很重要。虽然维生素D
补充剂被广泛用于改善骨骼健康,单独补充维生素D的试验减少了
骨折显示不一致的结果。新出现的证据表明,补充D在低的背景下,
维生素K状况对骨骼健康措施的影响较小。因此,低维生素K状态可能导致
一些测试维生素D和骨骼健康的试验不一致,可能导致毒性
由于高剂量的维生素D,如肾结石。以前没有随机对照试验,
有足够的把握来测试维生素K状态对骨折风险的影响或维生素K状态与
高剂量补充维生素D为了填补知识空白,我们提出了一项创新的辅助研究,
到大型,NIH赞助,维生素D和OmegA-3 TriaL(VITAL)。VITAL正在测试补充剂的效果
维生素D3(胆钙化醇,2000 IU/d)和/或ω-3脂肪酸(鱼油,1 g/d)在一级预防
25,871名美国男性(年龄≥50岁)和女性(年龄≥55岁)中的癌症和心血管疾病,包括5,106名
非裔美国人在这个竞争性的更新应用程序“重要:对骨结构和
架构,”我们将确定是否低维生素K状态,评估3个敏感的生物标志物,修改
补充维生素D对骨折、骨矿物质密度(BMD)和结构的影响,其次是
尿钙排泄增加,这是低骨密度和肾结石的危险因素。在第一个周期中,
我们超越了招募目标,收集了基线和随机化后2年的影像学研究,
将用于拟定研究的骨密度、结构和体系结构(n=771)。此外,其他
将利用关键的VITAL资源,包括:16,953份基线和6,000份随访血样;
维生素D、钙、肌酐和甲状旁腺激素的测量;以及判定的骨折和肾脏
石头这项提案提供了一个独特的机会,在最大的补充维生素D的研究中澄清,
维生素D和K的相互依赖性及其对骨折、骨骼健康指标和尿液的作用
钙排泄拟议的辅助研究的结果对于解释正在进行的
维生素D试验,并提供新的见解,以推进临床护理和公共卫生建议。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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MERYL Susan LEBOFF其他文献
MERYL Susan LEBOFF的其他文献
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{{ truncateString('MERYL Susan LEBOFF', 18)}}的其他基金
VITamin D OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers
维生素 D OmegA-3 TriaL (VITAL):骨折、维生素 D 和遗传标记
- 批准号:
10402353 - 财政年份:2018
- 资助金额:
$ 65.68万 - 项目类别:
VITamin D OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers
维生素 D OmegA-3 TriaL (VITAL):骨折、维生素 D 和遗传标记
- 批准号:
9902329 - 财政年份:2018
- 资助金额:
$ 65.68万 - 项目类别:
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
维生素 D 和 OmegA-3 TriaL:对骨骼结构和结构的影响
- 批准号:
8372176 - 财政年份:2012
- 资助金额:
$ 65.68万 - 项目类别:
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
维生素 D 和 OmegA-3 TriaL:对骨骼结构和结构的影响
- 批准号:
8704352 - 财政年份:2012
- 资助金额:
$ 65.68万 - 项目类别:
VITamin D and OmegA-3 TriaL (VITAL): Interrelationship of Vitamin D and Vitamin K on Bone
维生素 D 和 OmegA-3 TriaL (VITAL):维生素 D 和维生素 K 对骨骼的相互关系
- 批准号:
10453573 - 财政年份:2012
- 资助金额:
$ 65.68万 - 项目类别:
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
维生素 D 和 OmegA-3 TriaL:对骨骼结构和结构的影响
- 批准号:
9111834 - 财政年份:2012
- 资助金额:
$ 65.68万 - 项目类别:
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
维生素 D 和 OmegA-3 TriaL:对骨骼结构和结构的影响
- 批准号:
8519306 - 财政年份:2012
- 资助金额:
$ 65.68万 - 项目类别:
Vitamin D and Omega-3 Fatty Acids(VITAL Trial): Effects on Fractures
维生素 D 和 Omega-3 脂肪酸(VITAL 试验):对骨折的影响
- 批准号:
8528478 - 财政年份:2010
- 资助金额:
$ 65.68万 - 项目类别:
Vitamin D and Omega-3 Fatty Acids(VITAL Trial): Effects on Fractures
维生素 D 和 Omega-3 脂肪酸(VITAL 试验):对骨折的影响
- 批准号:
8318916 - 财政年份:2010
- 资助金额:
$ 65.68万 - 项目类别:
Vitamin D and Omega-3 Fatty Acids(VITAL Trial): Effects on Fractures
维生素 D 和 Omega-3 脂肪酸(VITAL 试验):对骨折的影响
- 批准号:
8055786 - 财政年份:2010
- 资助金额:
$ 65.68万 - 项目类别:
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