Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors in Obese Adolescents

NCT00858247 | Completed Phase 2 Results DMC

• 2 other identifiers: 08-008743UL1RR024150
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of obesity has reached epidemic proportions nationally as well as internationally. Currently, 16 % of American adolescents are obese. In adults, obesity is a risk factor for vitamin D insufficiency and up to 80% of obese adults have been noted to vitamin D insufficient. In adults, low vitamin D status appears to be associated with the development of type 2 diabetes and metabolic syndrome. There is little information on the prevalence of vitamin D insufficiency and its implications in obese adolescents. Additionally, it is unknown whether treatment of vitamin D insufficiency in adolescents might result in improvement in insulin resistance, lipids and cardiovascular risk markers. We hypothesize that vitamin D insufficiency correlates positively with insulin resistance and cardiovascular risk in obese adolescents and that vitamin D3 supplementation improves insulin resistance and cardiovascular risk factors in this population. The purpose of the study is to determine the impact of vitamin D3 supplementation on various parameters of insulin secretion, insulin action, lipids and C-reactive protein in obese adolescents.

Conditions

Obesity

Keywords

vitamin D; Obesity; Insulin sensitivity; Adolescent Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation

  Insulin resistance (IR) is a physiological condition in which cells fail to respond to the normal actions of the hormone insulin. The body produces insulin, but the cells in the body become resistant to insulin and are unable to use it as effectively, leading to hyperglycemia. Beta cells in the pancreas subsequently increase their production of insulin, further contributing to hyperinsulinemia. From the fasting glucose and insulin measurements, insulin resistance was calculated by the homeostasis model assessment of insulin resistance (HOMA -IR) as: HOMA -IR = fasting insulin concentration (µU/mL) x fasting glucose concentration (mmol/L)/22.5. High HOMA-IR scores denote increased insulin resistance.

  Baseline, 12 weeks

Secondary Outcomes (5)

• Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation

  baseline, 12 weeks

• Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation

  baseline, 12 weeks

• Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation

  baseline, 12 weeks

• Change in Triglycerides After 12 Weeks of Vitamin D Supplementation

  baseline, 12 weeks

• Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation

  baseline, 12 weeks

Study Arms (2)

Vitamin D3-low dose

EXPERIMENTAL

Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.

Dietary Supplement: Vitamin D3

Vitamin D3-high dose

EXPERIMENTAL

Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks.

Vitamin D3-high dose; Vitamin D3-low dose

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 12-18 years
• BMI is at or greater than the 95th percentile for age and gender

You may not qualify if:

• Subjects with 25 (OH)- D levels \>100 ng/mL
• Serum calcium \>10.8 mg/dL
• Current cancer
• Those taking a multivitamin supplementation
• Hepatic or renal disorders
• Type 1 or type 2 diabetes mellitus.
• Those receiving insulin, metformin or oral hypoglycemic medications
• Use of glucocorticoids and anti-seizure medications in the previous 6 months
• Malabsorption syndromes such as celiac disease

Sponsors & Collaborators

• Mayo Clinic: lead
• National Center for Research Resources (NCRR): collaborator
• Thrasher Research Fund: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Javed A, Vella A, Balagopal PB, Fischer PR, Weaver AL, Piccinini F, Dalla Man C, Cobelli C, Giesler PD, Laugen JM, Kumar S. Cholecalciferol supplementation does not influence beta-cell function and insulin action in obese adolescents: a prospective double-blind randomized trial. J Nutr. 2015 Feb;145(2):284-90. doi: 10.3945/jn.114.202010. Epub 2014 Dec 17.

  PMID: 25644349 DERIVED

MeSH Terms

Conditions

Obesity; Insulin Resistance; Pediatric Obesity

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Seema Kumar, MD
• Organization: Mayo Clinic

kumar.seema@mayo.edu

507-284-3300

Study Officials

• Seema Kumar, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 9, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 20, 2014
• Results First Posted: March 6, 2014

Record last verified: 2014-05

Locations

US (1)