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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：
MERYL Susan LEBOFF
金额：
$ 65.68万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
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：
https://reporter.nih.gov/project-details/10219961
关键词：
Affect African American American Ancillary Study Architecture Attenuated Biological Markers Blood specimen Body mass index Bone Density Bone Diseases Bone Matrix Bone structure Calcium Cardiovascular Diseases Cholecalciferol Collection Creatinine Deposition Deterioration Dose Dual-Energy X-Ray Absorptiometry Elderly Ethnic Origin Fasting Femoral Fractures Fish Oils Fracture Goals Grant Guidelines High Prevalence Hip Fractures Intake Intestines Kidney Kidney Calculi Knowledge Malignant Neoplasms Measures Medical Records Nephrolithiasis Norway Observational Study Omega-3 Fatty Acids Osteocalcin Osteoporosis Outcome PTH gene Parents Participant Peripheral Placebos Play Primary Cancer Prevention Production Proteins Public Health Questionnaires Race Randomized Randomized Controlled Trials Recommendation Resources Risk Risk Factors Rodent Model Role Serum Spottings Structure Supplementation Testing Tissues Toxic effect Trabecular Bone Score United States National Institutes of Health Urine Vitamin D Vitamin D Deficiency Vitamin D supplementation Vitamin K Vitamin K 1 Woman X-Ray Computed Tomography adjudicate adjudication age group aged bone bone health bone loss bone mass bone turnover calcification calcium absorption calcium excretion carboxylate carboxylation clinical care cohort cost cost efficient design dietary follow-up fracture risk fragility fracture high risk imaging study improved innovation insight matrix Gla protein men older men older women protein K protein function radiological imaging recruit sex soft tissue systematic 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