Clinical Study to Evaluate the Efficacy of 1,25(OH)2D3 (Calcitriol) Versus Placebo in Recent Onset Type 1 Diabetes(IMDIAB XIII)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 5
- 主要终点
- C peptide
研究概览
简要总结
Reduction in vitamin D levels has been reported in subjects with recent onset type 1 diabetes. Several studies suggest that vitamin D supplementation in early childhood decreases the risk of developing type 1 diabetes, therefore vitamin D deficiency might play a role in the disease pathogenesis. We investigated whether the supplementation of the active form of vitamin D (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual beta cell function evaluated by C peptide and improve glycaemic control as evaluated by HbA1c and insulin requirement.
Thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1 diabetes (<12 weeks duration) and high basal C-peptide >0.25 nmol/l were randomized in a double-blind trial to calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3 [1,25-(OH)2D3] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 11 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of type 1 diabetes according to the American Diabetes Association (ADA) guidelines;
- •age at presentation between 11 and 35 years;
- •duration of clinical disease (since the beginning of insulin therapy) <12 weeks;
- •baseline C-peptide >0.25 nmol/l;
- •no medical contra-indications or any other major chronic disease;
- •willingness and capability to participate in a regular follow-up.
排除标准
- •cardiovascular disease;
- •renal disease;
- •liver disease;
- •neurological disorders;
- •allergic diathesis;
- •hyperparathyroidism;
研究组 & 干预措施
placebo
干预措施: Calcitriol (Drug)
Calcitriol
干预措施: Calcitriol (Drug)
结局指标
主要结局
C peptide
evaluation of baseline and stimulated C peptide
次要结局
- Glycometabolic control