Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents
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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 |
- Cytokines [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 |
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
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| 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: | August 7, 2012 |
| 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 June 17, 2013