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| Sponsor: | Mayo Clinic |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00858247 |
Purpose
The prevalence of obesity has reached epidemic proportions nationally as well as internationally. Currently, 16 % of American adolescents are obese. In adults, obesity is a risk factor for vitamin D insufficiency and up to 80% of obese adults have been noted to vitamin D insufficient. In adults, low vitamin D status appears to be associated with the development of type 2 diabetes and metabolic syndrome. There is little information on the prevalence of vitamin D insufficiency and its implications in obese adolescents. Additionally, it is unknown whether treatment of vitamin D insufficiency in adolescents might result in improvement in insulin resistance, lipids and cardiovascular risk markers.
We hypothesize that vitamin D insufficiency correlates positively with insulin resistance and cardiovascular risk in obese adolescents and that vitamin D3 supplementation improves insulin resistance and cardiovascular risk factors in this population. The purpose of the study is to determine the impact of vitamin D3 supplementation on various parameters of insulin secretion, insulin action, lipids and C-reactive protein in obese adolescents.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Dietary Supplement: Vitamin D3 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Significance of Vitamin D Status in Obese Adolescents- A Pilot Study to Examine the Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors |
| Estimated Enrollment: | 130 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Vitamin D3-low dose: Experimental
Vitamin D3 400 IU/once daily
|
Dietary Supplement: Vitamin D3
One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks.
|
|
vitamin D3-high dose: Experimental
Vitamin D3 2000 IU/capsule, once capsule once daily
|
Dietary Supplement: Vitamin D3
One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks.
|
The problem of childhood obesity has reached epidemic proportions both nationally and internationally. The prevalence of obesity has tripled in the last three decades and currently 16 % of American adolescents are obese. Nearly 30% of obese adolescents demonstrate a metabolic syndrome characterized by insulin resistance and dyslipidemia. These abnormalities lead to the development of type 2 diabetes mellitus and to increased cardiovascular morbidity and mortality. Obesity is a well-known risk factor for vitamin D insufficiency and up to 80% of obese adults have been found to be insufficient in vitamin D. Observational studies in adults have shown consistent associations between low vitamin D status and prevalence of type 2 diabetes mellitus and metabolic syndrome. There is paucity of data on the prevalence of vitamin D insufficiency and its implications in obese adolescents. It is also not known whether treatment of vitamin D insufficiency in children or adults might result in improvement in insulin resistance and cardiovascular risk factors.
Hypotheses: We hypothesize that vitamin D insufficiency correlates positively with insulin resistance and cardiovascular risk in obese adolescents and that vitamin D3 supplementation decreases insulin resistance and cardiovascular risk factors in this population.
Objectives:
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Those receiving insulin, metformin or oral hypoglycemic medications
Contacts and Locations| Contact: Seema Kumar, M.D. | 507-284-3300 | kumar.seema@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Seema Kumar, M.D. | Mayo Clinic |
More Information
| Responsible Party: | Mayo Clinic ( Seema Kumar, M.D. ) |
| Study ID Numbers: | 08-008743, 1624 |
| Study First Received: | March 5, 2009 |
| Last Updated: | August 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00858247 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
vitamin D Obesity Insulin sensitivity Adolescent Obesity |
|
Obesity Cholecalciferol Metabolic Diseases Growth Substances Physiological Effects of Drugs Ergocalciferols Bone Density Conservation Agents Overweight Pharmacologic Actions Insulin Body Weight |
Hyperinsulinism Signs and Symptoms Hypoglycemic Agents Vitamin D Vitamins Nutrition Disorders Overnutrition Micronutrients Insulin Resistance Glucose Metabolism Disorders |