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

October 24, 2017 updated by: Laura K Bachrach, Stanford University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline; Week 24
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
Time Frame: Baseline; Week 24
Baseline; Week 24
High-density Lipoprotein (HDL) at Baseline and Week 24
Time Frame: Baseline; Week 24
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.
Baseline; Week 24
Interleukin-6 (IL-6) at Baseline and Week 24
Time Frame: Baseline; Week 24
Baseline; Week 24
Interleukin-10 (IL-10) at Baseline and Week 24
Time Frame: Baseline; Week 24
Baseline; Week 24
Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24
Time Frame: Baseline; Week 24
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.
Baseline; Week 24
Adiponectin at Baseline and Week 24
Time Frame: Baseline; Week 24
Baseline; Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Laura K Bachrach, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-10012010-6989
  • 18885 (Stanford IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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