The Effects of Vitamin D on Glycemic Control and Proinflammatory Markers in Adolescents With T1DM
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Diabetes |
Therapuetic Areas: | Endocrinology, Gastroenterology |
Healthy: | No |
Age Range: | 13 - 21 |
Updated: | 4/2/2016 |
Start Date: | October 2012 |
End Date: | June 2014 |
Contact: | Erin Shih, D.O. |
Email: | eshih@chla.usc.edu |
Phone: | (323) 361-8705 |
The Effects of Vitamin D Supplementation on Glycemic Control and Proinflammatory Markers Involved in Microvascular Complications in Adolescents With Type 1 Diabetes.
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.
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.
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.
We found this trial at
1
site
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
Click here to add this to my saved trials