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

Primary Purpose

Obesity, Glucose Intolerance, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Vitamin D 3 cholecalciferol
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

9 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo pill

Vitamin D

Arm Description

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 vitamin D3 (cholecalciferol) per day for 6 months.

Outcomes

Primary Outcome Measures

serum 25-hydroxy vitamin D concentrations
serum concentrations of inflammatory markers (Interleukin-6, TNF-alpha, c reactive protein)
Hemoglobin A1C, serum glucose and insulin concentrations

Secondary Outcome Measures

Body composition as measured by DXA
Body mass index

Full Information

First Posted
October 12, 2009
Last Updated
October 5, 2016
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00994396
Brief Title
Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents
Official Title
Use of Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents on a Standard Weight Loss Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Glucose Intolerance, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo pill
Arm Type
Placebo Comparator
Arm Description
Placebo soft gel pills (soy bean oil encapsulated in soft gel comprised of gelatin, glycerin and water) twice per day for 6 mos
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
4000 IU vitamin D3 (cholecalciferol) per day for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Reliance Private Label Supplements
Intervention Description
Placebo soft gel pills (soy bean oil encapsulated in soft gel comprised of gelatin, glycerin and water) twice per day for 6 mos.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D 3 cholecalciferol
Other Intervention Name(s)
Reliance Private Label Supplements
Intervention Description
4000 IU (2 soft gels at 2000 IU each) vitamin D3 per day for 6 months.
Primary Outcome Measure Information:
Title
serum 25-hydroxy vitamin D concentrations
Time Frame
baseline, 3, 6 months
Title
serum concentrations of inflammatory markers (Interleukin-6, TNF-alpha, c reactive protein)
Time Frame
baseline and 6 mos
Title
Hemoglobin A1C, serum glucose and insulin concentrations
Time Frame
baseline, 3 and 6 months
Secondary Outcome Measure Information:
Title
Body composition as measured by DXA
Time Frame
baseline and 6 mos
Title
Body mass index
Time Frame
baseline, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine A Peterson, Ph.D.
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23407306
Citation
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.
Results Reference
derived

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

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