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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Vitamin D
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br>Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months. | Drug: Vitamin D<br> <br> * Other names: Cholecalciferol;|
| Placebo Comparator: Placebo<br>Subjects will receive a placebo solution daily over the course of 9 months. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IDAA1c | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting c-peptide | Endogenous insulin production and secretion will be determined by measuring changes in fasting c-peptide levels at diagnosis and at 9 months of disease duration. | diagnosis and 9 months disease duration | 
| high sensitivity c-reactive protein (hsCRP) | Changes in systemic inflammation will be determined by measuring hsCRP at diagnosis and at 9 months of disease duration. | diagnosis and 9 months disease duration | 
| interleukin-6 (IL-6) | Changes in systemic inflammation will be determined by measuring IL-6 at diagnosis and 9 months of disease duration. | diagnosis and 9 months disease duration | 
| tumor necrosis factor-alpha (TNF-alpha) | Changes in systemic inflammation will be determined by measuring TNF-alpha at diagnosis and 9 months of disease duration. | diagnosis and 9 months disease duration | 
| 25-(OD)D | Comparisons will be made between 25-(OH)D status at diagnosis and 9 months disease duration with IDAA1c at 3, 6, and 9 months to assess the relationship between 25-(OD)D and our primary outcome of partial clinical remission. | diagnosis and 9 months disease duration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Vitamin D, Clinical Remission