Vitamin D and Glucose Metabolism in Pediatrics
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ClinicalTrials.gov Identifier: NCT01386736 |
Recruitment Status : Unknown
Verified June 2011 by Weill Medical College of Cornell University.
Recruitment status was: Recruiting
First Posted : July 1, 2011
Last Update Posted : July 1, 2011
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Condition or disease | Intervention/treatment | Phase |
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Insulin Resistance Obesity Vitamin D25 Insufficiency | Drug: Vitamin D drops Drug: Placebo drops | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Vitamin D Concentrations and Their Effect on Glucose Metabolism in Pediatrics |
Study Start Date : | April 2011 |
Estimated Primary Completion Date : | March 2012 |
Estimated Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Vitamin D
Subjects will randomly be assigned to Vitamin D drops versus placebo drops.
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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. |
- To determine changes in insulin sensitivity induced by vitamin D supplementation in obese children with insulin resistance. [ Time Frame: 4 months ]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.
- To quantify the associations between vitamin D 25 concentration, insulin resistance, and calcium metabolism in overweight children. [ Time Frame: 4 months ]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.

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Ages Eligible for Study: | 7 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386736
Contact: Maria Vogiatzi, MD | 212-746-3462 | mvogiatz@med.cornell.edu | |
Contact: Sadana Balachandar, MD | 212-746-3462 | sab9082@nyp.org |
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 |
Principal Investigator: | Maria Vogiatzi, MD | Weill Medical College of Cornell University |
Responsible Party: | Maria Vogiatzi, MD, Weill Cornell Medical College |
ClinicalTrials.gov Identifier: | NCT01386736 |
Other Study ID Numbers: |
0902010250 |
First Posted: | July 1, 2011 Key Record Dates |
Last Update Posted: | July 1, 2011 |
Last Verified: | June 2011 |
insulin resistance obesity adolescence vitamin D supplementation |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Vitamin D Vitamins |
Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |