An interventional study of Vitamin D and Placebo in Type 1 Diabetes, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Other
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 38 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.
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Exclusion Criteria:
Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months.
Drug: Vitamin D
Subjects will receive a placebo solution daily over the course of 9 months.
Drug: Placebo
Also known as: Cholecalciferol
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
| Milestone | Vitamin D | Placebo |
|---|---|---|
| Started | 19 | 18 |
| Completed | 15 | 14 |
| Not completed | 4 | 4 |
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.
| Participants | Vitamin D | Placebo |
|---|---|---|
| IDAA1c | 5 | 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin D | — | 0/15 (0%) | 0/15 (0%) |
| Placebo | — | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Vitamin D | Placebo | Total |
|---|---|---|---|
| <=18 years | 15 | 14 | 29 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Vitamin D | Placebo | Total |
|---|---|---|---|
| Mean | 9.875 ± 2.59 | 11.6 ± 3.28 | 10.7 ± 3.04 |
| Sex: Female, Male(Participants) | Vitamin D | Placebo | Total |
|---|---|---|---|
| Female | 5 | 8 | 13 |
| Male | 10 | 6 | 16 |
| Region of Enrollment(participants) | Vitamin D | Placebo | Total |
|---|---|---|---|
| United States | 15 | 14 | 29 |
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Nationwide Children's Hospital