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临床试验/NCT01724190
NCT01724190已完成不适用

Effect of Vitamin D Supplementation on Rate of Partial Clinical Remission in Children and Adolescents With Type 1 Diabetes

Nationwide Children's Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months.

干预措施: Vitamin D (Drug)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathryn Obrynba

Endocrinology Fellow

Nationwide Children's Hospital

研究点 (1)

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