Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents
Condition: Obesity; Glucose Intolerance; Inflammation
MeSH terms: Glucose Intolerance; Inflammation
Study type: Interventional

Summary: 
      The investigators' project will study the effects of optimizing the vit D status of obese
      adolescents on markers of glucose metabolism and inflammation.
    

Detailed description: 
      The alarming rise in pediatric obesity over the past few decades has been associated with an
      increase in the occurrence of impaired glucose tolerance and inflammation in children and
      adolescents. These conditions are part of the "metabolic syndrome", and children with risk
      factors such as these are much more likely to develop cardiovascular disease or diabetes as
      adults compared with their lean peers. Within the last few years there has been a growing
      body of evidence that optimizing vitamin D (vit D) status may alleviate these
      obesity-associated complications. Further, there is also research that shows that the better
      the vit D status of overweight individuals, the more favorably they respond to dieting by
      losing more body fat. The prevalence of vit D deficiency/insufficiency in the North American
      population has been classified as an "epidemic" by experts in the field and obese teens are
      considered at an even greater risk for deficiency because they tend to store vit D in their
      fat stores which is not readily mobilized for use by the body. The investigators' project
      will study the effects of optimizing the vit D status of obese adolescents on markers of
      glucose metabolism and inflammation. Obese teens attending an established adolescent weight
      loss clinic will be supplemented with high-dose vit D for 6 months (mos) which will be
      administered concurrently with their standard medical care and treatment. At baseline, 3 mos
      and 6 mos the investigators will measure vit D status, serum markers of insulin sensitivity
      and glucose metabolism; serum markers of inflammation; and body weight/height and waist
      circumference. At baseline and 6 mos only the investigators also measure body composition
      (percent body fat by dual-energy x-ray absorptiometry) and confounding lifestyle factors
      known to affect vit D, glucose metabolism or inflammation (e.g., nutrient intake, physical
      activity, sun exposure, pubertal stage). Results gleaned from this study will help to advance
      the prevention and treatment of obesity-related complications and have the potential to lead
      to significant reductions in healthcare costs and co-morbidities.
    

Intervention name(s): Placebo; Vitamin D 3 cholecalciferol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo soft gel pills (soy bean oil encapsulated in soft gel comprised of gelatin, glycerin and water) twice per day for 6 mos.; 4000 IU (2 soft gels at 2000 IU each) vitamin D3 per day for 6 months.
Other intervention name(s): Reliance Private Label Supplements; Reliance Private Label Supplements
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment