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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Drug: Drisdol (Ergocalciferol) Vitamin D2; Drug: Placebo

• Registration Number: NCT01217840
• Lead Sponsor: Stanford University

Brief Summary

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).

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2015-02-13
• Results First Submitted QC: 2015-02-13
• Results First Posted: 2015-03-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Ages 11 years to 17.99 years old
2. BMI: 85 percentile for age and gender

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin D	Drisdol (Ergocalciferol) Vitamin D2	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
Placebo	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

Primary Outcome Measures

Name	Time	Method
25OH Vitamin D	Baseline; Week 24	Primary outcome is serum 25OH vitamin D concentrations

Secondary Outcome Measures

Name	Time	Method
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	Baseline; Week 24	HbgA1c is a test to measure of the glucose (blood sugar) level over the past 2-3 months.
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	Baseline; Week 24	Outcome was assessed using high-sensitivity C-reactive protein (hs-CRP) test.
Adiponectin at Baseline and Week 24	Baseline; Week 24

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States