Type 1 Diabetes, Vitamin D Deficiency/Insufficiency
Conditions
Keywords
Diabetes, Vitamin D, Proinflammatory markers
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Between 13 to 21 years of age, with at least Tanner stage 4 sexual maturity for males or post-menarchal females, and T1DM for at least 1 year. To ensure that inclusion criteria for sexual maturity are met, a physical exam for research purposes will be performed. 2. HbA1c between 7 to 9% 3. Adequate renal function (serum creatinine \< 1.5 mg/dL in males and \< 1.2 mg/dL in females) and adequate liver function (AST and ALT \< 2.5 times the upper limit of normal) 4. Vitamin D insufficiency or deficiency (25-OH vit D level \< 30ng/mL) which will be determined on initial screening labs after consenting subjects.
Exclusion criteria
1. Less than 13 or greater than 21 years of age 2. Less than Tanner stage 4 sexual maturity for males or pre-menarche 3. HbA1c less than 7% or greater than 9% 4. T1DM for less than 1 year 5. Vitamin D sufficient (25-OH vit D level \> 30 ng/mL) 6. Currently taking any medication that can interfere with vitamin D synthesis or metabolism, including but not limited to Orlistat, Phenobarbital, Dilantin, Anti-tuberculosis drugs 7. Currently taking any medication other than insulin that alters blood glucose levels, including but not limited to systemic glucocorticoids 8. Inadequate renal function (serum creatinine \> 1.5mg/dL in males and \> 1.2mg/dL in females) or inadequate liver function (AST and ALT \> 2.5 times the upper limit of normal) 9. Evidence of malabsorption or short gut.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 6 months | The primary endpoint in this study will be the difference in change in Hemoglobin A1c between the treatment and non-treatment periods (6 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pro-inflammatory markers | 6 months | Change in pro-inflammatory markers (CRP, IL-6, TNF-α) between treatment and non-treatment periods |
| Vitamin D level and proinflammatory markers | 6 months | Correlation between change in vitamin D levels and circulating pro-inflammatory markers, including CRP, IL-6, and TNF-α |
| Vitamin D levels on insulin requirements | 6 months | Correlation between the change of vitamin D levels on insulin requirements |
| Vitamin D level and HbA1c | 6 months | Correlation between the change in vitamin D level in the blood and change in HbA1c |
| Baseline differences between vitamin D deficient & sufficient subjects | Baseline | 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 |
Countries
United States
Outcome results
None listed