Effect of Vitamin D on the Honeymoon Period in Children and Adolescents With Type 1 Diabetes

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

children and adolescents ages 4-18 years old with newly diagnosed type 1 diabetes.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will receive a placebo solution daily over the course of 9 months.
Vitamin D	Vitamin D	Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months.

Primary Outcome Measures

Name	Time	Method
IDAA1c	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.

Secondary Outcome Measures