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N/A N=40 Randomized Triple-blind Treatment

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

Obesity

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: 25OH Vitamin D — 19.6; 25.8; 20.1; 24.6 ng/mL

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Drisdol (Ergocalciferol) Vitamin D2 (Drug); Placebo (Drug)
Age
Pediatric · 11+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Aug 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
25OH Vitamin D
19.6; 25.8; 20.1; 24.6
SECONDARY
Triglycerides at Baseline and Week 24
106; 99; 114; 99
SECONDARY
High-density Lipoprotein (HDL) at Baseline and Week 24
41; 46; 41; 47
SECONDARY
Hemoglobin A1C (HgbA1c) at Baseline and Week 24
5.4; 5.3; 5.4; 5.3
SECONDARY
Interleukin-6 (IL-6) at Baseline and Week 24
1.0; 0.7; 1.0; 0.7
SECONDARY
Interleukin-10 (IL-10) at Baseline and Week 24
1.7; 2.0; 1.7; 2.3
SECONDARY
Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24
6.0; 7.2; 6.9; 7.5
SECONDARY
C-reactive Protein (CRP) at Baseline and Week 24
4.0; 2.2; 4.3; 2.3
SECONDARY
Adiponectin at Baseline and Week 24
4.8; 7.2; 5.9; 7.3

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).

Eligibility Criteria

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01217840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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