The Effect of Vitamin D on Cytokines and Cardiometabolic Risk in Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 25OH Vitamin D
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 11 years to 17.99 years old
- •BMI: 85 percentile for age and gender
排除标准
- •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
- •diabetes mellitus
- •liver or kidney disease
- •malabsorptive disorders
- •genetic syndromes associated with obesity (i.e. Prader-Willi)
- •lactose deficiency or insufficiency
- •galactosemia
研究组 & 干预措施
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
干预措施: Drisdol (Ergocalciferol) Vitamin D2 (Drug)
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
干预措施: Placebo (Drug)
结局指标
主要结局
25OH Vitamin D
时间窗: Baseline; Week 24
Primary outcome is serum 25OH vitamin D concentrations
次要结局
- Triglycerides at Baseline and Week 24(Baseline; Week 24)
- High-density Lipoprotein (HDL) at Baseline and Week 24(Baseline; Week 24)
- Interleukin-10 (IL-10) at Baseline and Week 24(Baseline; Week 24)
- Hemoglobin A1C (HgbA1c) at Baseline and Week 24(Baseline; Week 24)
- Interleukin-6 (IL-6) at Baseline and Week 24(Baseline; Week 24)
- Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24(Baseline; Week 24)
- C-reactive Protein (CRP) at Baseline and Week 24(Baseline; Week 24)
- Adiponectin at Baseline and Week 24(Baseline; Week 24)
研究者
Laura K Bachrach
Principle Investigator
Stanford University