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Effect of Vitamin D Supplementation on Oral Glucose Tolerance Among Obese Adolescents

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4,000 IU vitamin D3
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

9 Years - 19 Years (Child, Adult)All SexesAccepts 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
  • 25OH vitamin D level within past 3 months

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, hypercalciuria, or hypercalcemia
  • undergoing UV radiation as medical therapy
  • pregnancy; cigarette smoking; current use of a tanning bed
  • current type 2 diabetes
  • any current antihyperglycemic medication use (e.g. metformin, insulin) less than one month prior to initial OGTT.

Sites / Locations

  • University of Missouri Adolescent Obesity Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

4,000 IU Vitamin D3

Arm Description

two 2,000 IU vitamin D3 pills (total 4,000 IU) daily for six months.

Outcomes

Primary Outcome Measures

change in oral glucose tolerance
Will obtain oral glucose tolerance tests at baseline and at 6 months to determine change

Secondary Outcome Measures

Full Information

First Posted
May 10, 2013
Last Updated
October 6, 2016
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01856946
Brief Title
Effect of Vitamin D Supplementation on Oral Glucose Tolerance Among Obese Adolescents
Official Title
Effect of 4,000 IU Vitamin D3 Supplementation on Oral Glucose Tolerance Among Vitamin D Deficient Obese Adolescent
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Childhood obesity is a rapidly growing epidemic in the US and the world. Current estimates suggest that 30% of our nation's children are either overweight ot obese. Obesity is a major risk factor towards the development of insulin resistance, which, in turn is a major risk factor for the development of type 2 diabetes. Prior research has suggested that vitamin D therapy may be a safe, inexpensive, and effective method of reducing insulin resistance and a person's risk of developing diabetes. The investigators' prior studies have shown that daily 4,000 IU vitamin D therapy is a safe and effective method of improving insulin resistance based on a calculation called the HOMA-IR. The next step in identifying whether vitamin D truly improves insulin resistance is to use oral glucose tolerance testing (OGTT), which is a better real-life measure of insulin resistance compared to the previously used HOMA-IR.
Detailed Description
The investigators intend to recruit 20 obese adolescent subjects from the PI's obesity clinic to participate in the study. Investigators expect 5 to drop out, therefore leaving 15 subjects to complete the study. Eligible and assenting subjects (with consent from a parent) will be admitting to the Pediatric Procedure Suite and MU Women's and Children's Hospital. They will have an IV placed in the arm by a nurse experienced with working with children. The subjects will have blood drawn from the IV checking for vitamin D level, insulin, glucose, and c-peptide level (another marker for insulin status). The subject will then be asked to drink a 75 gram glucose solution. Additional blood will be drawn from the IV site to check for glucose, insulin, and c-peptide levels at 30 minutes, 60 minutes, 90 minutes, and 120 minutes. A total of 30 mL (2 tablespoons) of blood will be drawn that day. The subject will have the IV removed and will be discharged to then take two 2,000 IU vitamin D3 pills (total 4,000 IU) daily for six months. At a routine 3 months clinical visit, the subject will be tested for routine, standard of care, basic metabolic profile (BMP) with 4 ml of blood (less than 1 teaspoon) to assess for high calcium levels, a potential complication of vitamin D therapy. In the investigators' previous study of adolescents taking 4,000 IU vitamin D daily for six months, no subject developed a high calcium level. At six months, the subject will return to the Pediatric procedure suite to have another OGTT and labs via IV as described above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4,000 IU Vitamin D3
Arm Type
Experimental
Arm Description
two 2,000 IU vitamin D3 pills (total 4,000 IU) daily for six months.
Intervention Type
Dietary Supplement
Intervention Name(s)
4,000 IU vitamin D3
Intervention Description
two 2,000 IU vitamin D3 pills (total 4,000 IU) daily for six months.
Primary Outcome Measure Information:
Title
change in oral glucose tolerance
Description
Will obtain oral glucose tolerance tests at baseline and at 6 months to determine change
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 25OH vitamin D level within past 3 months 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, hypercalciuria, or hypercalcemia undergoing UV radiation as medical therapy pregnancy; cigarette smoking; current use of a tanning bed current type 2 diabetes any current antihyperglycemic medication use (e.g. metformin, insulin) less than one month prior to initial OGTT.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aneesh K Tosh, MD. MS
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Adolescent Obesity Clinic
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States

12. IPD Sharing Statement

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
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Effect of Vitamin D Supplementation on Oral Glucose Tolerance Among Obese Adolescents

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