CLINICAL TRIAL: TREATMENT OF HYPOVITAMINOSIS D AND PREDIABETES IN MINORITIES: A

临床试验：少数族裔维生素 D 缺乏症和糖尿病前期的治疗：A

• 批准号: 8359853
• 负责人: THEODORE FRIEDMAN
• 金额: $ 3.64万
• 依托单位: CHARLES R. DREW UNIVERSITY OF MED & SCI
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8359853
• 关键词: Cholecalciferol; Clinical Treatment; Clinical Trials; Data; Dose; Funding; Glycemic Index; Grant; Impaired fasting glycaemia; Liquid substance; Minority; Minority Groups; National Center for Research Resources; Normal Range; Outcome; Patients; Placebos; Prediabetes syndrome; Principal Investigator; Research; Research Infrastructure; Resources; Serum; Source; Supplementation; Translational Research; United States National Institutes of Health; Vitamin D; Vitamin Deficiency; cost; design; fasting glucose; impaired glucose tolerance; insulin secretion; insulin sensitivity

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. We hypothesize that vitamin D supplementation reduced the progression of pre-diabetes [impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT)] in a dose-dependent manner compared to placebo administration. prior to resubmitting our NIH grant, we wish to obtain pilot data to determine if a) using a monthly dose of liquid vitamin D3) , we are able to raise serum 25-OHD into the upper normal range and 2) whether this effects glycemic indices, including fasting glucose levels and calculations o insulin sensitivity and insulin secretion. Aim: To treat primarily ethnic/racial minority patients with hypovitaminosis D [vitamin D levels less than 30 ni/mL] and pre-diabetes with placebo or two doses of vitamin D3 (300,000 IU of liquid Vit D on day 1 and day 30) designed to raise serum 25-Ohd into the upper normal range. Outcomes will include changes from baseline in fasting glucose levels and estimates of insulin sensitivity and insulin secretion.

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 我们假设，与安慰剂给药相比，维生素D补充剂以剂量依赖性方式降低了糖尿病前期[空腹血糖受损（IFG）和/或糖耐量受损（IGT）]的进展。在重新提交我们的NIH拨款之前，我们希望获得试验数据以确定a）使用每月剂量的液体维生素D3），我们是否能够将血清25-OHD提高到正常范围的上限，和2）这是否影响血糖指数，包括空腹葡萄糖水平和胰岛素敏感性和胰岛素分泌的计算。 目的：主要用安慰剂或两剂维生素D3（第1天和第30天300，000 IU液体维生素D）治疗维生素D缺乏症D [维生素D水平低于30 mg/mL]和糖尿病前期的少数民族/种族患者，旨在将血清25-Ohd升高至正常范围上限。结果将包括空腹血糖水平较基线的变化以及胰岛素敏感性和胰岛素分泌的估计值。