Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Vitamin D, Clinical Remission
Brief summary
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
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.
Interventions
DRUGVitamin D
DRUGPlacebo
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IDAA1c | 9 months disease duration | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months.
Vitamin D | 15 |
| Placebo Subjects will receive a placebo solution daily over the course of 9 months.
Placebo | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | Placebo | Vitamin D | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 15 Participants | 29 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.6 years STANDARD_DEVIATION 3.28 | 9.875 years STANDARD_DEVIATION 2.59 | 10.7 years STANDARD_DEVIATION 3.04 |
| Region of Enrollment United States | 14 participants | 15 participants | 29 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
Primary
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.
Time frame: 9 months disease duration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vitamin D | IDAA1c | 5 Participants |
| Placebo | IDAA1c | 2 Participants |