Vitamin D and Glucose Metabolism in Pediatrics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01386736
First received: April 18, 2011
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Insulin Resistance
Obesity
Vitamin D25 Insufficiency
Drug: Vitamin D drops
Drug: Placebo drops
Phase 4

Study Type: 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
Official Title: Vitamin D Concentrations and Their Effect on Glucose Metabolism in Pediatrics

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • To determine changes in insulin sensitivity induced by vitamin D supplementation in obese children with insulin resistance. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To quantify the associations between vitamin D 25 concentration, insulin resistance, and calcium metabolism in overweight children. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The normal values for vitamin D are not standardized. In children, it is generally accepted, that vitamin D25 levels>20ng/ml are indicative of vitamin D sufficiency. Data in adults, however, suggest that this cutoff for vitamin D sufficiency should be raised to greater than 30ng/ml. Analysis of bone metabolism in this study will give some insight to the effects of vitamin D treatment in this population of children, and may help further define acceptable vitamin D levels in determining vitamin D deficiency and insufficiency. Our timeframe is baseline and 4 months.


Estimated Enrollment: 110
Study Start Date: April 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D
Subjects will randomly be assigned to Vitamin D drops versus placebo drops.
Drug: Vitamin D drops
Subjects will be randomly assigned to Vitamin D 3,000 Units per day or Placebo drops.
Placebo Comparator: Placebo
Subjects will randomly be assigned to Vitamin D drops versus placebo drops.
Drug: Placebo drops
Subjects will be randomly assigned to Vitamin D 3,000 Units per day or Placebo drops.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386736

Contacts
Contact: Maria Vogiatzi, MD 212-746-3462 mvogiatz@med.cornell.edu
Contact: Sadana Balachandar, MD 212-746-3462 sab9082@nyp.org

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Sadana Balachandar, MD    212-746-3462    sab9082@nyp.org   
Principal Investigator: Maria Vogiatzi, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Maria Vogiatzi, MD Weill Medical College of Cornell University
  More Information

Publications:

Responsible Party: Maria Vogiatzi, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT01386736     History of Changes
Other Study ID Numbers: 0902010250
Study First Received: April 18, 2011
Last Updated: June 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
insulin resistance
obesity
adolescence
vitamin D supplementation

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Body Weight
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014