Efficacy of Vitamin D Therapy on Glucose Homeostasis in Obese Adolescents

Completed · Not applicable · Has a placebo group

Conditions studied: Vitamin D Deficiency

In brief

The purpose of this study is to see whether giving a Vitamin D supplement to vitamin D deficient obese children and adolescents will decrease the risk of getting diabetes (Disease in which the person has high blood sugar). The number of vitamin D deficiency in U.S. children and teenagers has grown dramatically over the past 30 years. There are some reports suggesting that vitamin D supplementation in adults with pre diabetes (blood glucose higher than normal) and vitamin D treatment will prevent diabetes.

Key facts

Study ID

NCT02414529

Run by

NYU Langone Health

People needed

20

Starts

2013-11-01

Expected to finish

2015-10-01

Last updated by the study team

2017-03-17

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Obese subjects - BMI at or above the 95th percentile for children of the same age and sex. Only obese subjects will be selected given that they are the highest risk group of developing insulin resistance and Type II Diabetes and therefore with be most likely to demonstrate glucose pertubation.
• Pubertal: Testicular volume ≥ 6 ml Prader (M) and Tanner III breast development or greater (F)
• 12- 18 years regardless of gender, race or economic circumstance
• Pre diabetes/high risk of diabetes using criteria of HbA1C between 5.7 - 6.4% as defined by the American Diabetes Association (ADA)
• 25-OH vitamin D level less than 20 ng/ml (50 nmol/liter)
• Subjects must be willing to comply with study protocol requirements

You may not qualify if…

• Treatment on medication known to effect vitamin D, calcium and glucose metabolism, such as glucocorticoids, thiazolidinediones, metformin, anticonvulsants metabolized through cytochrome P-450 (phenytoin, carbamazepine, phenobarbital, sodium valproate).
• Subjects will be excluded from the study if they have taken any form of vitamin D supplementation greater than 400 IU daily in the preceding 3 months.
• Significant major organ system illness
• History of nephrolithiasis or hypercalcemia
• Females who are pregnant
• Significant psychiatric illness: schizophrenia, bipolar disorder, active substance abuse, and uncontrolled major depression.
• Attendance at tanning salon

Where it is running

• bellevue hospital CTSI — New York, New York, United States

Full record on ClinicalTrials.gov

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