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Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Missouri-Columbia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Catherine Peterson, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00994396
First received: October 12, 2009
Last updated: September 21, 2011
Last verified: September 2011

October 12, 2009
September 21, 2011
November 2009
August 2011   (final data collection date for primary outcome measure)
  • serum 25-hydroxy vitamin D concentrations [ Time Frame: baseline, 3, 6 months ] [ Designated as safety issue: No ]
  • serum concentrations of inflammatory markers (Interleukin-6, TNF-alpha, c reactive protein) [ Time Frame: baseline and 6 mos ] [ Designated as safety issue: No ]
  • Hemoglobin A1C, serum glucose and insulin concentrations [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00994396 on ClinicalTrials.gov Archive Site
  • Body composition as measured by DXA [ Time Frame: baseline and 6 mos ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents
Use of Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents on a Standard Weight Loss Program

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Glucose Intolerance
  • Inflammation
  • Dietary Supplement: Placebo
    Placebo soft gel pills (soy bean oil encapsulated in soft gel comprised of gelatin, glycerin and water) twice per day for 6 mos.
    Other Name: Reliance Private Label Supplements
  • Dietary Supplement: Vitamin D 3 cholecalciferol
    4000 IU (2 soft gels at 2000 IU each) vitamin D3 per day for 6 months.
    Other Name: Reliance Private Label Supplements
  • Placebo Comparator: Placebo pill
    Intervention: Dietary Supplement: Placebo
  • Experimental: Vitamin D
    4000 IU vitamin D3 (cholecalciferol) per day for 6 months.
    Intervention: Dietary Supplement: Vitamin D 3 cholecalciferol
Belenchia AM, Tosh AK, Hillman LS, Peterson CA. Correcting vitamin D insufficiency improves insulin sensitivity in obese adolescents: a randomized controlled trial. Am J Clin Nutr. 2013 Apr;97(4):774-81. doi: 10.3945/ajcn.112.050013. Epub 2013 Feb 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obese adolescent (BMI > 85th percentile for age)
  • 9-19 years of age
  • attending the ADOBE clinic at the University of Missouri

Exclusion Criteria:

  • use of vit D supplements other than standard multi-vitamin preparation
  • (i.e., should not be receiving vit D > 1000 IU/d) use of medications that interfere with vit D metabolism (e.g., anti-convulsive)
  • history of hepatic or renal disorders;
  • undergoing ultraviolet radiation as medical therapy;
  • pregnancy;
  • cigarette smoking;
  • current use of commercial tanning bed;
Both
9 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00994396
1139897
No
Catherine Peterson, University of Missouri-Columbia
University of Missouri-Columbia
Not Provided
Principal Investigator: Catherine A Peterson, Ph.D. University of Missouri-Columbia
University of Missouri-Columbia
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP