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.
抽象的
骨质疏松症是最常见的骨病; 5360 万美国人骨量减少,
增加了脆性骨折的风险。除了维生素 D 缺乏症的高患病率之外,最近
研究表明,大约 60% 的老年男性和 40% 的老年女性维生素 K 不足
摄入量。越来越多的证据表明维生素 D 和维生素之间存在重要的相互关系
骨头上的K。维生素 D 增加肠道钙吸收并刺激两种蛋白质的产生,
骨钙素和基质 Gla 蛋白。维生素 K 在激活这些蛋白质方面发挥着重要作用,因此
骨钙素将钙结合到骨骼和基质中 Gla 蛋白抑制软组织的钙化,包括
肾脏。维生素 D 和 K 对于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 的试验可减少骨骼健康
骨折结果不一致。新出现的证据表明,在低水平的情况下补充 D
维生素 K 状态对骨骼健康措施的影响较小。因此,维生素 K 水平低可能是导致
测试维生素 D 和骨骼健康的试验存在一些不一致之处,可能会导致毒性
归因于高剂量维生素 D,如肾结石。之前没有进行过随机对照试验
足以测试维生素 K 状态对骨折风险的影响或维生素 K 状态与骨折风险的相互作用
高剂量补充骨骼维生素 D。为了填补知识空白,我们提出了一项创新的辅助研究
NIH 赞助的大型维生素 D 和 OmegA-3 TriaL (VITAL)。 VITAL 正在测试补充品的效果
维生素 D3(胆钙化醇,2000 IU/天)和/或 omega-3 脂肪酸(鱼油,1 g/天)用于一级预防
25,871 名美国男性(年龄≥50 岁)和女性(年龄≥55 岁)患有癌症和心血管疾病,其中 5,106 名
非裔美国人。在“VITAL:对骨结构和骨结构的影响”的竞争性更新应用中
架构”,我们将确定通过 3 种敏感生物标志物评估的低维生素 K 状态是否会改变
补充维生素 D 对骨折、骨矿物质密度 (BMD) 和结构的影响,其次是对
尿钙排泄增加,这是低骨密度和肾结石的危险因素。在本次第一个周期中
拨款,我们超越了招募目标,并收集了基线和 2 年随机化后成像研究
将在拟议研究中使用的骨密度、结构和架构 (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 份后续血液样本;
维生素 D、钙、肌酐和甲状旁腺激素的测量;并判定骨折和肾脏
石头。该提案提供了一个独特的机会,可以在最大规模的补充维生素 D 研究中阐明,
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
钙的排泄。拟议的辅助研究的结果对于解释正在进行的研究至关重要
维生素 D 试验并为推进临床护理和公共卫生建议提供新见解。
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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