Recruiting

Vitamin D

Sponsor:

Weill Medical College of Cornell University

Code:

NCT01386736

Conditions

Insulin Resistance

Obesity

Vitamin D25 Insufficiency

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Accepted

Interventions

Vitamin D drops

Placebo drops

Study Details

Brief summary:

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.

Conditions

Insulin Resistance

Obesity

Vitamin D25 Insufficiency

Study ID

NCT01386736

Start date

Apr, 2011

Status verified date

Jun, 2011

Completion date

Mar, 2012

Anticipated

Primary completion date

Mar, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Vitamin D

Subjects will randomly be assigned to Vitamin D drops versus placebo drops.

placebo comparator: Placebo

Subjects will randomly be assigned to Vitamin D drops versus placebo drops.

Interventions

Vitamin D drops

Subjects will be randomly assigned to Vitamin D 3,000 Units per day or Placebo drops.

Placebo drops

Subjects will be randomly assigned to Vitamin D 3,000 Units per day or Placebo drops.

Primary outcome measure

  • To determine changes in insulin sensitivity induced by vitamin D supplementation in obese children with insulin resistance. [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

Contacts

Sadana Balachandar, MD

212-746-3462sab9082@nyp.org

Principal Investigator:

Maria Vogiatzi, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jul 1, 2011

Last verified

Jun, 2011

Keywords

  • insulin resistance
  • obesity
  • adolescence
  • vitamin D supplementation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2011-07-01.