Vitamin D Insufficiency in Pre- and Early Adolescent Children

青春期前和早期儿童维生素 D 不足

基本信息

批准号：
8131288
负责人：
KUMARAVEL RAJAKUMAR
金额：
$ 4.19万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-30 至 2012-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8131288
关键词：
10 year old 12 year old 14 year old 25-hydroxyvitamin D Address Adolescent Adult Adverse event Affect African African American Area Attitude Behavior Belief Body mass index Bone Resorption C-terminal Calcium Caucasians Caucasoid Race Child Childhood Chronic Clinical Clinical Data Clinical Research Collagen Type I Consent Cyclophosphamide Data Development Development Plans Diabetes Mellitus Dietary intake Disabled Persons Enrollment Ensure Epidemiology Fracture Future Goals High Prevalence Hormones Hyperparathyroidism Intake Knowledge Literature Longitudinal Studies Malabsorption Syndromes Malignant neoplasm of prostate Master of Science Measures Medical Medicine Mentors Metabolic Metabolism Minerals Minority Monitor Osteogenesis Osteoporosis Outcome Measure Parathyroid Hormones Parents Phase Physiological Pilot Projects Placebos Population Population Study Prevalence Prevention Principal Investigator Procollagen Public Health Recruitment Activity Research Research Design Research Personnel Rickets Risk Safety School-Age Population Seasonal Variations Secondary Hyperparathyroidism Serum Staging Sun Exposure Supplementation Surveys Testing Treatment Efficacy Trust Vitamin D Vitamins base bone bone health bone loss bone mass bone metabolism bone turnover career development caucasian American cohort crosslink falls handicapping condition health disparity human PTH protein improved indexing meetings minority health nutrition parental role primary outcome programs racial difference racial/ethnic difference randomized placebo controlled trial secondary outcome skeletal skeletal disorder social

项目摘要

DESCRIPTION (provided by applicant): My long- term goal is to become a proficient independent clinical researcher addressing racial and ethnic differences in vitamin D and calcium nutrition. My career development plan includes a Master of Science in Clinical Research and mentored clinical and social research. I plan to study the vitamin D status of pre- and early adolescent African American and Caucasian children. Epidemiologic and clinical data document a high prevalence of vitamin D insufficiency among adults and adolescents in the US. Little is known about the prevalence, seasonal variation and the metabolic impact of vitamin D insufficiency in preadolescent children. In Phase 1, using a longitudinal study design, we will estimate the prevalence and seasonal variation of vitamin D insufficiency in children 6 to 12 years old and characterize its impact on bone metabolism. A cohort of 140 healthy pre- and early adolescent children (6-12 yrs old, Tanner I or II, African American [n=94] and Caucasian [n=46]) will be studied during summer (June through September) and winter (December through March). Vitamin D status, calcitrophic hormones and markers of bone turnover will be assessed during summer and winter. Other measures include dietary intakes of vitamin D and calcium, sun exposure and body mass index. This study will help establish the prevalence, seasonal variation, metabolic impact of vitamin D insufficiency in young school-age African American and Caucasian children. In phase 2,168 (African American: 84, Caucasian: 84) 8 to 14 year old preadolescent and adolescent children will undergo a randomized-placebo controlled trial (RCT) of vitamin D31000 ID daily vs. placebo for 6 months initiated during fall and winter (October through March). This study will determine the serum 25(OH)D cutoff for the definition of vitamin D insufficiency and document the safety and efficacy of treatment on vitamin D status. To address issues of health disparities we will use the study design to test the hypothesis that parental mistrust in medicine and research is a barrier to recruitment of African American children into clinical research compared to Caucasian children. Parents of children recruited for the vitamin D study will be surveyed. Differences in the trust index between consenting and declining groups of parents will be determined. The results should help develop strategies for overcoming those barriers. Prevention of vitamin D insufficiency in children will improve their bone health (increase the peak bone mass) and reduce their "osteoporosis burden" during adulthood. Optimizing vitamin D status in African American children may have the potential to reduce the disparities from non-skeletal disorders associated with chronic vitamin D insufficiency such as diabetes and prostate cancer that disproportionately affect African American adults.

描述（由申请人提供）：我的长期目标是成为一名熟练的独立临床研究人员，以解决维生素D和钙营养中的种族和种族差异。我的职业发展计划包括临床研究的科学硕士，并指导了临床和社会研究。我计划研究非裔美国人和青春期前和白人儿童的维生素D状况。流行病学和临床数据记录了美国成年人和青少年的维生素D不足患病率。关于维生素D不足儿童的患病率，季节性变异和代谢影响知之甚少。在第1阶段，使用纵向研究设计，我们将估计6至12岁儿童中维生素D不足的患病率和季节性变化，并表征了其对骨代谢的影响。将在夏季（6月至9月）和冬季（12月至3月）中研究140名健康前和青春期儿童（6-12岁，Tanner I或II，II或II，非裔美国人[n = 94]和高加索人[n = 46]）的队列。夏季和冬季将评估维生素D状态，钙嗜激素和骨转换的标志物。其他措施包括维生素D和钙的饮食摄入量，阳光暴露和体重指数。这项研究将有助于确定年轻的非裔美国人和高加索儿童的维生素D不足的患病率，季节性变化，维生素D不足的代谢影响。在第2,168阶段（非裔美国人：84，高加索人：84）8至14岁的青春期和青春期儿童将在秋季和冬季（10月至3月）中进行维生素D31000 ID每日维生素D31000 ID与安慰剂6个月的随机地位对照试验（RCT）。这项研究将确定血清25（OH）D临界值，以定义维生素D不足，并记录治疗对维生素D状态的安全性和功效。为了解决健康差异问题，我们将使用研究设计来检验以下假设：与高加索儿童相比，医学和研究的父母不信任是将非裔美国儿童招募到临床研究的障碍。招募维生素D研究的儿童父母将接受调查。将确定同意和下降父母群体之间信任指数的差异。结果应有助于制定克服这些障碍的策略。预防儿童维生素D不足将改善其骨骼健康（增加峰值骨骼质量），并减轻成年期的“骨质疏松负担”。在非洲裔美国儿童中优化维生素D状态可能有可能减少与慢性维生素D不足有关的非骨骼疾病的差异，例如糖尿病和前列腺癌，这些疾病会对非裔美国人成年人产生不成比例的影响。