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Completed

NCT Number: NCT01217840

Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors 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).

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 11 years to 17.99 years old
  • BMI: 85 percentile for age and gender

Exclusion criteria

  • Patients who currently receive:
  • vitamin D supplementation >= 400 IU/day
  • daily glucocorticoids or anti-epileptics
  • 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

Treatment and study plan

Drisdol (Ergocalciferol) Vitamin D2

Drug

Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.

Placebo

Drug

Placebo pill - 3 pills every 12 weeks for total of 24 weeks

Primary outcomes

  1. 25OH Vitamin D

    Time frame: Baseline; Week 24

    Primary outcome is serum 25OH vitamin D concentrations

Secondary outcomes

  1. Triglycerides at Baseline and Week 24

    Time frame: Baseline; Week 24

  2. High-density Lipoprotein (HDL) at Baseline and Week 24

    Time frame: Baseline; Week 24

  3. 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.

  4. Interleukin-6 (IL-6) at Baseline and Week 24

    Time frame: Baseline; Week 24

  5. Interleukin-10 (IL-10) at Baseline and Week 24

    Time frame: Baseline; Week 24

  6. Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24

    Time frame: Baseline; Week 24

  7. 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.

  8. Adiponectin at Baseline and Week 24

    Time frame: Baseline; Week 24

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 8, 2010
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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