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

Obesity Clinical Trial

Official title:

Use of Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents on a Standard Weight Loss Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994396
• Other study ID #: 1139897
• Status: Completed
• Phase: N/A
• First received: October 12, 2009
• Last updated: October 5, 2016
• Start date: November 2009
• Est. completion date: April 2013

Study information

• Verified date: October 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2013
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 19 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Inflammation
• Obesity

Intervention

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.
• Vitamin D 3 cholecalciferol
4000 IU (2 soft gels at 2000 IU each) vitamin D3 per day for 6 months.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25-hydroxy vitamin D concentrations		baseline, 3, 6 months	No
Primary	serum concentrations of inflammatory markers (Interleukin-6, TNF-alpha, c reactive protein)		baseline and 6 mos	No
Primary	Hemoglobin A1C, serum glucose and insulin concentrations		baseline, 3 and 6 months	No
Secondary	Body composition as measured by DXA		baseline and 6 mos	No
Secondary	Body mass index		baseline, 3 and 6 months	No