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Vitamin D Concentrations and Their Effect on Glucose Metabolism in Pediatrics


Phase 4
7 Years
18 Years
Open (Enrolling)
Both
Insulin Resistance, Obesity, Vitamin D25 Insufficiency

Thank you

Trial Information

Vitamin D Concentrations and Their Effect on Glucose Metabolism in Pediatrics


Inclusion Criteria:



1. BMI>85th% for age & sex

2. Vitamin D25 between 10-20ng/ml

3. Normal serum Ca concentrations >8.5mg/dl

4. Evidence of insulin resistance (measured by HOMA-IR, and QUICKI indices)

Exclusion Criteria:

1. Vitamin D25<10ng/ml

2. No parental consent

3. No evidence of insulin resistance

4. BMI < 85th percentile

5. Known diagnosis of type 1 or 2 diabetes

6. Severe underlying disease such as liver disease, end-stage renal disease, or
malignancy

7. Present medication that affects insulin sensitivity such as steroids or Metformin

8. Any chronic illness or administration of medications that is associated with fat
malabsorption as they may interfere with vitamin D absorption.

9. Known history of hypocalcemia, calcium disorder (such as Di George syndrome)

10. Serum Calcium concentration < 8.5mg/dl

11. Other drugs that might effect vitamin D metabolism due to induction of P450 enzyme
activity.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

To determine changes in insulin sensitivity induced by vitamin D supplementation in obese children with insulin resistance.

Outcome Description:

To our knowledge, there are no prospective randomized clinical trials on examining the effects of vitamin D treatment on insulin resistance and bone metabolism in vitamin D deficient, insulin resistant, obese children. We would like to determine if giving Vitamin D supplementation to obese children will help reduce their insulin resistance. We plan to measure Vitamin D levels and HOMA-IR at baseline and compare this to levels post-supplementation. Our timeframe is baseline and 4 months.

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Maria Vogiatzi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Institutional Review Board

Study ID:

0902010250

NCT ID:

NCT01386736

Start Date:

April 2011

Completion Date:

March 2012

Related Keywords:

  • Insulin Resistance
  • Obesity
  • Vitamin D25 Insufficiency
  • insulin resistance
  • obesity
  • adolescence
  • vitamin D supplementation
  • Insulin Resistance
  • Obesity

Name

Location

Weill Cornell Medical CollegeNew York, New York  10021