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



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:11 - 17
Updated:12/1/2017
Start Date:September 2010
End Date:August 2012

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The Effect of Vitamin D on Cytokines and Cardiometabolic Risk 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).

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.

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
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