VITamin D and OmegA-3 TriaL (VITAL): Interrelationship of Vitamin D and Vitamin K on Bone
VITamin D and OmegA-3 TriaL (VITAL): Interrelationship of Vitamin D and Vitamin K on Bone
批准号:
10219961
负责人:
MERYL Susan LEBOFF
金额:
$65.68万
依托单位国家:
美国
项目类别:
财政年份:
2012
资助国家:
美国
项目状态:
已结题
起止时间:
2012-08-01 至 2023-07-31
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
中文摘要
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,是低BMD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。
英文摘要
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.
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会议论文
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资助金额:$28.58万
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资助金额:$27.15万
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Vitamin D and Omega-3 Fatty Acids(VITAL Trial): Effects on Fractures
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批准号:8528478
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资助金额:$18.53万
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财政年份:2010
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负责人:MERYL Susan LEBOFF
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资助金额:$19.51万
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依托单位:
Vitamin D and Omega-3 Fatty Acids(VITAL Trial): Effects on Fractures
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批准号:8055786
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资助金额:$20.32万
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资助金额:$19.51万
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负责人:MERYL Susan LEBOFF
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BONE HEALTH, STRESS FRACTURES, AND VITAMIN D DEFICIENCY IN ADULTS
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批准号:7719319
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资助金额:$0.11万
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负责人:MERYL Susan LEBOFF
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依托单位:
THE EFFECTS OF AGE AND VITAMIN D STATUS ON BONE
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批准号:7719339
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资助金额:$0.04万
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