The Effects of Vitamin D on Glycemic Control and Proinflammatory Markers in Adolescents With T1DM

Completed · Not applicable

Conditions studied: Type 1 Diabetes, Vitamin D Deficiency/Insufficiency

In brief

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.

Key facts

Study ID

NCT01697228

Run by

Children's Hospital Los Angeles

People needed

26

Starts

2012-10-01

Expected to finish

2014-06-01

Last updated by the study team

2017-05-08

Who can join

Age: 13 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• HbA1c between 7 to 9%
• 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)
• Vitamin D insufficiency or deficiency (25-OH vit D level < 30ng/mL) which will be determined on initial screening labs after consenting subjects.

You may not qualify if…

• Less than 13 or greater than 21 years of age
• Less than Tanner stage 4 sexual maturity for males or pre-menarche
• HbA1c less than 7% or greater than 9%
• T1DM for less than 1 year
• Vitamin D sufficient (25-OH vit D level > 30 ng/mL)
• Currently taking any medication that can interfere with vitamin D synthesis or metabolism, including but not limited to Orlistat, Phenobarbital, Dilantin, Anti-tuberculosis drugs
• Currently taking any medication other than insulin that alters blood glucose levels, including but not limited to systemic glucocorticoids
• 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)
• Evidence of malabsorption or short gut.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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