Phase 2 N=51 Randomized Quadruple-blind Prevention

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

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00858247 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation — 0.01; -0.27 HOMA score — p=0.95

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Vitamin D3 (Dietary_supplement)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation	0.01; -0.27	0.95
SECONDARY Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation	4.7; 3.5	0.80
SECONDARY Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation	4.6; 1.3	0.65
SECONDARY Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation	1.3; 1.9	0.68
SECONDARY Change in Triglycerides After 12 Weeks of Vitamin D Supplementation	-4.7; 1.7	0.40
SECONDARY Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation	-0.2; -0.5	0.47

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00858247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.