N/A
N=40
Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01217840 ↗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
| Outcome | Result | p-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
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.