Vitamin D and Glucose Metabolism in Pediatrics

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Insulin Resistance, Obesity, Vitamin D25 Insufficiency

In brief

The discovery that the vitamin D receptor is expressed in more than 30 tissues indicates that the physiologic functions of vitamin D are much broader than its well-known role in the regulation of calcium absorption and bone metabolism. There is evidence that vitamin D is involved in the pathogenesis of cancer, cardiovascular disease, multiple sclerosis, and type I diabetes. Recent epidemiological evidence points to a strong association between vitamin D insufficiency and insulin resistance, the metabolic syndrome, and type II diabetes. The investigators would like to examine the role of vitamin D in the development of insulin resistance in overweight children and adolescents, which represent a high risk population for cardiovascular and metabolic complications. The investigators propose a prospective randomized clinical trial of vitamin D supplementation in overweight, insulin resistant, vitamin D deficient children. The investigators objective is to assess if changes in insulin resistance, fasting lipid profiles, blood pressure, and inflammatory markers occur in these patients post treatment with vitamin D. Additionally, concomitant changes in calcium and bone metabolism after vitamin D treatment will be evaluated. This is because, contrary to adults, the optimal vitamin D concentrations that regulate calcium and bone metabolism have not been established in pediatrics.

Key facts

Study ID

NCT01386736

Run by

Weill Medical College of Cornell University

People needed

110

Starts

2011-04-01

Expected to finish

2012-03-01

Last updated by the study team

2011-07-01

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• BMI>85th% for age \& sex
• Vitamin D25 between 10-20ng/ml
• Normal serum Ca concentrations >8.5mg/dl
• Evidence of insulin resistance (measured by HOMA-IR, and QUICKI indices)

You may not qualify if…

• Vitamin D25<10ng/ml
• No parental consent
• No evidence of insulin resistance
• BMI < 85th percentile
• Known diagnosis of type 1 or 2 diabetes
• Severe underlying disease such as liver disease, end-stage renal disease, or malignancy
• Present medication that affects insulin sensitivity such as steroids or Metformin
• Any chronic illness or administration of medications that is associated with fat malabsorption as they may interfere with vitamin D absorption.
• Known history of hypocalcemia, calcium disorder (such as Di George syndrome)
• Serum Calcium concentration < 8.5mg/dl
• Other drugs that might effect vitamin D metabolism due to induction of P450 enzyme activity.

Where it is running

• Weill Cornell Medical College — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.