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
  Purpose

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.


Condition Intervention
Obesity
Glucose Intolerance
Inflammation
Dietary Supplement: Placebo
Dietary Supplement: Vitamin D 3 cholecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents on a Standard Weight Loss Program

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo pill 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
Experimental: Vitamin D
4000 IU vitamin D3 (cholecalciferol) per day for 6 months.
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

  Eligibility

Ages Eligible for Study:   9 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994396

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65211
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Catherine A Peterson, Ph.D. University of Missouri-Columbia
  More Information

No publications provided by University of Missouri-Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine Peterson, Associate Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00994396     History of Changes
Other Study ID Numbers: 1139897
Study First Received: October 12, 2009
Last Updated: September 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Obesity
Glucose Intolerance
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 26, 2014