Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This project is designed to study the role of vitamin D supplementation on the honeymoon
      phase of type 1 diabetes in children who are on standardized insulin treatment. The results
      could lead to significant changes in the approach to the early phase of type 1 diabetes with
      a strong emphasis on prolonging the honeymoon phase by using vitamin D and maintaining these
      patients on a standardized insulin regimen. The overall goal is to reduce the long-term
      complications of type 1 diabetes.
    

Detailed description: 
      Prolonging the duration of the partial clinical remission (PCR), or 'honeymoon' phase, of
      type 1 diabetes (T1D) improves glycemic control and reduces long-term complications. Recent
      studies suggest the exciting possibility that vitamin D supplementation, a safe and
      easy-to-implement therapy in children, may lengthen PCR and increase residual beta cell
      function (RBCF).

      However, existing studies employed a suboptimal vitamin D dose or lacked a standardized
      insulin treatment protocol, precluding solid conclusions and preventing the field from moving
      forward with translation to clinical practice. This trial's rationale is to securely
      establish the effect of an adequate dose of vitamin D on PCR and RBCF.

      We hypothesize that vitamin D will increase RBCF and prolong PCR. The primary aim is to
      determine the effect of adjunctive vitamin D on RBCF and PCR in youth with T1D maintained on
      a standardized insulin protocol. We propose a 12-month randomized, double-blind,
      placebo-controlled, parallel design trial of ergocalciferol vs. placebo in 40 subjects of
      10-21 years with newly-diagnosed T1D. The primary outcome is the change over time in
      stimulated C-peptide (a measure of RBCF). Secondary outcomes include change over time in
      insulin-dose-adjusted-hemoglobin-A1c (HbA1c) (IDAA1C; a measure of PCR), HbA1c, and total
      daily dose of insulin. Mechanistic studies will explore whether beneficial effects of vitamin
      D are associated with increased GLP-1 levels or decreased inflammatory markers, and whether
      response to vitamin D is impacted by T1D-risk polymorphisms. If our hypotheses are true,
      these findings may completely alter the approach to the early management of T1D, with strong
      emphasis on prolonging the honeymoon phase using a readily available and easily affordable
      vitamin D while maintaining these patients on a standardized insulin treatment regimen.
    

Intervention name(s): Ergocalciferol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months; Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
Other intervention name(s): Vitamin D
Intervention MeSH terms: Vitamin D; Ergocalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 12-month randomized, double-blind, placebo-controlled, parallel design trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 1 diabetes; vitamin D; honeymoon phase