Effect of Vitamin D Supplementation on Rate of Partial Clinical Remission in Children and Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- IDAA1c
研究概览
简要总结
The purpose of this study is to determine if supplementation with Vitamin D in children and adolescents with newly diagnosed type 1 diabetes increases the number of patients who enter the honeymoon period.
详细描述
Type 1 diabetes is an autoimmune disease characterized by destruction of the insulin secreting beta-cells of the pancreas. There is evidence that Vitamin D may play a role in the initial risk of development of autoimmune disease, including type 1 diabetes. However, Vitamin D may also play a role the natural progression of type 1 diabetes by altering innate insulin secretion and sensitivity and by influencing systemic inflammation, directly at the level of the beta-cell. Studies have shown that Vitamin D insufficiency or deficiency is frequently reported in children and adolescents with type 1 diabetes. A majority of newly diagnosed patients with type 1 diabetes enter a period of partial clinical remission, characterized by low or even absent insulin requirements, also known as a honeymoon period. This honeymoon period is associated with improved metabolic control, near normal insulin sensitivity, and recovery of beta-cell function leading to preservation of endogenous insulin secretion. We hypothesize that supplementation with Vitamin D in children and adolescents with newly diagnosed type 1 diabetes will halt the destructive process within the beta cell and improve beta-cell function by increasing endogenous insulin secretion and decreasing systemic inflammation, thereby increasing the rate of partial clinical remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children and adolescents ages 4-18 years old with newly diagnosed type 1 diabetes.
排除标准
- •age less than 4 years
- •pregnant females
- •previous or known history of Vitamin D deficiency or insufficiency
- •current use of Vitamin D supplementation or multi-vitamin containing >800 IU daily
- •or concurrent development and/or history of other significant systemic illness or non-endocrine autoimmune disorder.
研究组 & 干预措施
Vitamin D
Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months.
干预措施: Vitamin D (Drug)
Placebo
Subjects will receive a placebo solution daily over the course of 9 months.
干预措施: Placebo (Drug)
结局指标
主要结局
IDAA1c
时间窗: 9 months disease duration
Our primary outcome measure will be to determine the rate of partial clinical remission at 9 months of disease duration, which will be assessed by determining insulin dose adjusted hemoglobin A1c (IDAA1c) using the formula (HbA1c% + \[4 x insulin dose u/kg/day\]). A IDAA1c \<9 will be indicative of partial clinical remission.
次要结局
未报告次要终点
研究者
Kathryn Obrynba
Endocrinology Fellow
Nationwide Children's Hospital
