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

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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.


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
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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