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):
Stanford University
ClinicalTrials.gov Identifier:
NCT01217840
First received: October 7, 2010
Last updated: December 2, 2013
Last verified: December 2013
  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:
  • Cytokines [ 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 ]

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: Active vitamin D Drug: Drisdol (Ergocalciferol) Vitamin D2
Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
Placebo Comparator: Sugar Pill Drug: Placebo
Placebo pill - 3 pills every 12 weeks for total of 24 weeks

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
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
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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01217840     History of Changes
Other Study ID Numbers: SU-10012010-6989, 18885
Study First Received: October 7, 2010
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Adolescents, Vitamin D

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014