Clinical trial NCT01217840: Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents
Official title: The Effect of Vitamin D on Cytokines and Cardiometabolic Risk in Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Adolescents, Vitamin D
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 25OH Vitamin D
timeFrame: Baseline; Week 24
Secondary outcomes:
measure: Triglycerides at Baseline and Week 24
timeFrame: Baseline; Week 24
measure: High-density Lipoprotein (HDL) at Baseline and Week 24
timeFrame: Baseline; Week 24
measure: Hemoglobin A1C (HgbA1c) at Baseline and Week 24
timeFrame: Baseline; Week 24
measure: Interleukin-6 (IL-6) at Baseline and Week 24
timeFrame: Baseline; Week 24
measure: Interleukin-10 (IL-10) at Baseline and Week 24
timeFrame: Baseline; Week 24
measure: Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24
timeFrame: Baseline; Week 24
measure: C-reactive Protein (CRP) at Baseline and Week 24
timeFrame: Baseline; Week 24
measure: Adiponectin at Baseline and Week 24
timeFrame: Baseline; Week 24
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Laura K Bachrach
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah S, Wilson DM, Bachrach LK. Large Doses of Vitamin D Fail to Increase 25-Hydroxyvitamin D Levels or to Alter Cardiovascular Risk Factors in Obese Adolescents: A Pilot Study. J Adolesc Health. 2015 Jul;57(1):19-23. doi: 10.1016/j.jadohealth.2015.02.006. Epub 2015 Apr 11.