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

4 Years
18 Years
Not Enrolling
Type 1 Diabetes

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Outcome Measure:


Outcome Description:

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.

Outcome Time Frame:

9 months disease duration

Safety Issue:


Principal Investigator

Kathryn J Stephens, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nationwide Children's Hospital


United States: Institutional Review Board

Study ID:




Start Date:

November 2012

Completion Date:

March 2014

Related Keywords:

  • Type 1 Diabetes
  • Type 1 Diabetes
  • Vitamin D
  • Clinical Remission
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 1



Nationwide Children's HospitalColumbus, Ohio  43205-2696