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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laura K Bachrach, Stanford University
ClinicalTrials.gov Identifier:
NCT01217840
First received: October 7, 2010
Last updated: February 13, 2015
Last verified: February 2015
  Purpose

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).


Condition Intervention
Obesity
Drug: Drisdol (Ergocalciferol) Vitamin D2
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin D on Cytokines and Cardiometabolic Risk in Obese Adolescents

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 25OH Vitamin D [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid Profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Glucose Metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Inflammatory Cytokines [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   11 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01217840

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Laura K Bachrach Stanford University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laura K Bachrach, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01217840     History of Changes
Other Study ID Numbers: SU-10012010-6989  18885 
Study First Received: October 7, 2010
Results First Received: February 13, 2015
Last Updated: February 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Adolescents, Vitamin D

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 29, 2016