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

NCT01856946 | Completed

• 1 other identifier: 1203853
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• change in oral glucose tolerance

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

  baseline and 6 months

Study Arms (1)

4,000 IU Vitamin D3

EXPERIMENTAL

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

Dietary Supplement: 4,000 IU vitamin D3

Interventions

4,000 IU vitamin D3 DIETARY_SUPPLEMENT

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

4,000 IU Vitamin D3

Eligibility Criteria

• Age: 9 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Obese adolescent (BMI \>85th percentile for age)
• years of age
• attending the ADOBE clinic at the University of Missouri
• OH vitamin D level within past 3 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Adolescent Obesity Clinic

Columbia, Missouri, 65201, United States

Location

Related Publications (1)

• 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.

  PMID: 23407306 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Aneesh K Tosh, MD. MS

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 20, 2013
• Study Start: May 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

US (1)