Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents
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|ClinicalTrials.gov Identifier: NCT01217840|
Recruitment Status : Completed
First Posted : October 8, 2010
Results First Posted : March 2, 2015
Last Update Posted : November 29, 2017
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 or disease||Intervention/treatment||Phase|
|Obesity||Drug: Drisdol (Ergocalciferol) Vitamin D2 Drug: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effect of Vitamin D on Cytokines and Cardiometabolic Risk in Obese Adolescents|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: vitamin D
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
Drug: Drisdol (Ergocalciferol) Vitamin D2
Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
Placebo Comparator: 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
Placebo pill - 3 pills every 12 weeks for total of 24 weeks
- 25OH Vitamin D [ Time Frame: Baseline; Week 24 ]Primary outcome is serum 25OH vitamin D concentrations
- Triglycerides at Baseline and Week 24 [ Time Frame: Baseline; Week 24 ]
- High-density Lipoprotein (HDL) at Baseline and Week 24 [ Time Frame: Baseline; Week 24 ]
- 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.
- Interleukin-6 (IL-6) at Baseline and Week 24 [ Time Frame: Baseline; Week 24 ]
- Interleukin-10 (IL-10) at Baseline and Week 24 [ Time Frame: Baseline; Week 24 ]
- Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24 [ Time Frame: Baseline; Week 24 ]
- 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.
- Adiponectin at Baseline and Week 24 [ Time Frame: Baseline; Week 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217840
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Laura K Bachrach||Stanford University|