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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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.
9 months disease duration
Kathryn J Stephens, MD
Nationwide Children's Hospital
United States: Institutional Review Board
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