Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents

Study Overview
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Brief Summary
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Large studies of children show that over half of the children in the United States of America do not have enough vitamin D stored in their bodies. In children who are overweight or obese, the percentage of children who do not have enough vitamin D is even higher. Vitamin D is essential for the body to maintain normal calcium levels and strong bones. Recent research shows that through the actions of inflammatory markers, levels in the blood that measure inflammation in the body, vitamin D plays many other important roles in the body like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat. The purpose of this study is to determine the effect of vitamin D supplementation on inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin D stores and inflammatory cytokines. In an observed, randomized controlled trial over 6 months we will provide observed vitamin D supplementation or placebo to healthy obese and overweight adolescents and measure changes in inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that administration of vitamin D to these patients will improve their inflammatory profile and cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).

Detailed Description
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Supplementation with vitamin D at 150,000 IU every 3 months failed to increase serum 25-hydroxy vitamin D (25OHD) or alter inflammatory markers and lipids in overweight and obese youth. Further studies are needed to establish the dose of vitamin D required to increase 25OHD and determine potential effects on metabolic risk factors in obese teens. During the course of the study, blood pressure removed from the prespecified outcome measures.

Official Title
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The Effect of Vitamin D on Cytokines and Cardiometabolic Risk in Obese Adolescents

Conditions
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Obesity

Intervention / Treatment
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* Drug: Drisdol (Ergocalciferol) Vitamin D2
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 11 years to 17.99 years old BMI: 85 percentile for age and gender Exclusion Criteria: Patients who currently receive: vitamin D supplementation >= 400 IU/day daily glucocorticoids or anti-epileptics Patients who currently have or history of: 25-OH vitamin D level < 10 ng/ml or > 60 ng/ml rickets diabetes mellitus liver or kidney disease malabsorptive disorders genetic syndromes associated with obesity (i.e. Prader-Willi) lactose deficiency or insufficiency galactosemia

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D<br>Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks | Drug: Drisdol (Ergocalciferol) Vitamin D2<br>* Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.<br>|
| Placebo Comparator: Placebo<br>Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks | Drug: Placebo<br>* Placebo pill - 3 pills every 12 weeks for total of 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25OH Vitamin D | Primary outcome is serum 25OH vitamin D concentrations | Baseline; Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides at Baseline and Week 24 |  | Baseline; Week 24 | 
| High-density Lipoprotein (HDL) at Baseline and Week 24 |  | Baseline; Week 24 | 
| Hemoglobin A1C (HgbA1c) at Baseline and Week 24 | HbgA1c is a test to measure of the glucose (blood sugar) level over the past 2-3 months. | Baseline; Week 24 | 
| Interleukin-6 (IL-6) at Baseline and Week 24 |  | Baseline; Week 24 | 
| Interleukin-10 (IL-10) at Baseline and Week 24 |  | Baseline; Week 24 | 
| Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24 |  | Baseline; Week 24 | 
| C-reactive Protein (CRP) at Baseline and Week 24 | Outcome was assessed using high-sensitivity C-reactive protein (hs-CRP) test. | Baseline; Week 24 | 
| Adiponectin at Baseline and Week 24 |  | Baseline; Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Vitamin D