ACTRN12612000714886已完成不适用
Effect of vitamin D supplementation on glucose control and inflammatory response in type II diabetic patients.
Albany College of Pharmacy and Health Sciences (ACPHS)0 个研究点目标入组 22 人开始时间: 2012年7月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 21 Years 至 75 Years（—）
- 性别
- All
入选标准
- •* Adult (aged 21-75 year-old) at start of screening.
- •* Type II Diabetic patients.
- •* A1C level (> or =) 6 within the last 3 months.
- •* Insulin Resistance based on Homeostatic model assessment (HOMA-IR) (> or =) 2
- •* Serum 25-hydroxyvitamin D level (25(OH)D) level < (20 ng/ml) (50 nmol/l)
- •* Normal kidney function (eGFR > 90) using CKD-EPI formula
- •* On a stable oral hypoglycemic drug regimen for at least 30 days prior to screening. Those who are on thiazolidinedione should be on stable regimen for at least 6 months prior to screening.
- •* On stable regimen of lipid lowering drug for at least 30 days prior to screening or not on one at all.
- •* On stable regimen of antihypertensive drugs for at least 30 days prior to screening or not on one at all.
排除标准
- •1)History of any of the following diseases:
- •A)Chronic kidney diseases eGFR < 90
- •B)Chronic liver disease.
- •C)Congestive heart failure.
- •D)Myocardial infarction (MI) within the last 6 months.
- •E)History of cerebrovascular accident.
- •F)Hypercalcemia (serum calcium > 10.2 mg/dl)
- •G)Proteinurea (> 3.5 g/24 hours)
- •H)Autoimmune or inflammatory diseases [(e.g.
- •sarcoidosis, systemic lupus erythematous (SLE),
- •rheumatoid arthritis (RA)].
- •I)Gastrointestinal malabsorption disorders (e.g.
- •celiac, crohn’s disease)
- •J)Primary parathyroid disorders.
- •K)malignancy
- •2)Currently taking any of the following drugs:
- •B)Activated Vitamin D analogs or nutritional vitamin
- •D agents > 800 IU/day
- •C)Glucocorticoid
- •D)Antiepeleptic (e.g. phenytoin, phosphenytoin,
- •barbiturate, primidone)
- •E)Carbamezapine
- •G)Cholestyramine
- •3) History of gastric bypass surgery or removal of part of stomach or small intestine.
- •4) Pregnant or breastfeeding.
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