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

Nationwide Children's Hospital

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Drug: Placebo; Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01724190

285412

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

Vitamin D

Active Comparator group

Description:

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

Treatment:

Drug: Vitamin D

Placebo

Placebo Comparator group

Description:

Subjects will receive a placebo solution daily over the course of 9 months.

Treatment:

Drug: Placebo