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The investigators are conducting a prospective cross-over study to evaluate the effects of vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to see a significant improvement in glycemic control and a reduction of serum pro-inflammatory markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who are treated with vitamin D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate treatment group | Other | This group will receive vitamin D supplementation for the first 6 months, then will be monitored off vitamin D for the next 6 months. |
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| Delayed treatment group | Other | This group will be monitored for the first 6 months, and then will be given vitamin D for the next 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | The primary endpoint in this study will be the difference in change in Hemoglobin A1c between the treatment and non-treatment periods (6 months) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pro-inflammatory markers | Change in pro-inflammatory markers (CRP, IL-6, TNF-α) between treatment and non-treatment periods | 6 months |
| Vitamin D level and proinflammatory markers | Correlation between change in vitamin D levels and circulating pro-inflammatory markers, including CRP, IL-6, and TNF-α |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roshanak Monzavi, M.D. | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D014808 | Vitamin D Deficiency |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| 6 months |
| Vitamin D levels on insulin requirements | Correlation between the change of vitamin D levels on insulin requirements | 6 months |
| Vitamin D level and HbA1c | Correlation between the change in vitamin D level in the blood and change in HbA1c | 6 months |
| Baseline differences between vitamin D deficient & sufficient subjects | Comparison of baseline differences between vitamin D deficient/insufficient subjects and vitamin D sufficient subjects (including pro-inflammatory markers, HbA1c and total daily insulin requirements | Baseline |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |