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

The Effect of Vitamin D on Cytokines and Cardiometabolic Risk in Obese Adolescents

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).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Drisdol (Ergocalciferol) Vitamin D2; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Drisdol (Ergocalciferol) Vitamin D2; Ergocalciferol 150,000 IU every 12 weeks for total of 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	Drug: Placebo; Placebo pill - 3 pills every 12 weeks for total of 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
25OH Vitamin D	Primary outcome is serum 25OH vitamin D concentrations	Baseline; Week 24

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Laura K Bachrach, Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 7, 2010
• First Submitted That Met QC Criteria: October 7, 2010
• First Posted (Estimate): October 8, 2010

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Adolescents, Vitamin D
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Ergocalciferols
• Other Study ID Numbers: SU-10012010-6989; 18885 (Stanford IRB)