Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents

Overview

Large studies of children show that over half of the children in the United States of America do not have enough vitamin D stored in their bodies. In children who are overweight or obese, the percentage of children who do not have enough vitamin D is even higher. Vitamin D is essential for the body to maintain normal calcium levels and strong bones. Recent research shows that through the actions of inflammatory markers, levels in the blood that measure inflammation in the body, vitamin D plays many other important roles in the body like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat. The purpose of this study is to determine the effect of vitamin D supplementation on inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin D stores and inflammatory cytokines. In an observed, randomized controlled trial over 6 months we will provide observed vitamin D supplementation or placebo to healthy obese and overweight adolescents and measure changes in inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that administration of vitamin D to these patients will improve their inflammatory profile and cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).

Full Title of Study: “The Effect of Vitamin D on Cytokines and Cardiometabolic Risk in Obese Adolescents”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 2012

Detailed Description

Supplementation with vitamin D at 150,000 IU every 3 months failed to increase serum 25-hydroxy vitamin D (25OHD) or alter inflammatory markers and lipids in overweight and obese youth. Further studies are needed to establish the dose of vitamin D required to increase 25OHD and determine potential effects on metabolic risk factors in obese teens. During the course of the study, blood pressure removed from the prespecified outcome measures.

Interventions

  • Drug: Drisdol (Ergocalciferol) Vitamin D2
    • Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
  • Drug: Placebo
    • Placebo pill – 3 pills every 12 weeks for total of 24 weeks

Arms, Groups and Cohorts

  • Experimental: vitamin D
    • Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
  • Placebo Comparator: Placebo
    • Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks

Clinical Trial Outcome Measures

Primary Measures

  • 25OH Vitamin D
    • Time Frame: Baseline; Week 24
    • Primary outcome is serum 25OH vitamin D concentrations

Secondary Measures

  • Triglycerides at Baseline and Week 24
    • Time Frame: Baseline; Week 24
  • High-density Lipoprotein (HDL) at Baseline and Week 24
    • Time Frame: Baseline; Week 24
  • Hemoglobin A1C (HgbA1c) at Baseline and Week 24
    • Time Frame: Baseline; Week 24
    • HbgA1c is a test to measure of the glucose (blood sugar) level over the past 2-3 months.
  • Interleukin-6 (IL-6) at Baseline and Week 24
    • Time Frame: Baseline; Week 24
  • Interleukin-10 (IL-10) at Baseline and Week 24
    • Time Frame: Baseline; Week 24
  • Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24
    • Time Frame: Baseline; Week 24
  • C-reactive Protein (CRP) at Baseline and Week 24
    • Time Frame: Baseline; Week 24
    • Outcome was assessed using high-sensitivity C-reactive protein (hs-CRP) test.
  • Adiponectin at Baseline and Week 24
    • Time Frame: Baseline; Week 24

Participating in This Clinical Trial

Inclusion Criteria

1. Ages 11 years to 17.99 years old 2. BMI: 85 percentile for age and gender Exclusion Criteria:

1. Patients who currently receive:

  • vitamin D supplementation >= 400 IU/day – daily glucocorticoids or anti-epileptics 2. Patients who currently have or history of: – 25-OH vitamin D level < 10 ng/ml or > 60 ng/ml – rickets – diabetes mellitus – liver or kidney disease – malabsorptive disorders – genetic syndromes associated with obesity (i.e. Prader-Willi) – lactose deficiency or insufficiency – galactosemia

Gender Eligibility: All

Minimum Age: 11 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Laura K Bachrach, Principle Investigator – Stanford University
  • Overall Official(s)
    • Laura K Bachrach, Principal Investigator, Stanford University

Citations Reporting on Results

Shah S, Wilson DM, Bachrach LK. Large Doses of Vitamin D Fail to Increase 25-Hydroxyvitamin D Levels or to Alter Cardiovascular Risk Factors in Obese Adolescents: A Pilot Study. J Adolesc Health. 2015 Jul;57(1):19-23. doi: 10.1016/j.jadohealth.2015.02.006. Epub 2015 Apr 11.

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