The Effects of Vitamin D Supplementation on Glycemic Control and Proinflammatory Markers Involved in Microvascular Complications in Adolescents With Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The investigators are conducting a prospective cross-over study to evaluate the effects of vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to see a significant improvement in glycemic control and a reduction of serum pro-inflammatory markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who are treated with vitamin D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 13 to 21 years of age, with at least Tanner stage 4 sexual maturity for males or post-menarchal females, and T1DM for at least 1 year. To ensure that inclusion criteria for sexual maturity are met, a physical exam for research purposes will be performed.
- •HbA1c between 7 to 9%
- •Adequate renal function (serum creatinine < 1.5 mg/dL in males and < 1.2 mg/dL in females) and adequate liver function (AST and ALT < 2.5 times the upper limit of normal)
- •Vitamin D insufficiency or deficiency (25-OH vit D level < 30ng/mL) which will be determined on initial screening labs after consenting subjects.
排除标准
- •Less than 13 or greater than 21 years of age
- •Less than Tanner stage 4 sexual maturity for males or pre-menarche
- •HbA1c less than 7% or greater than 9%
- •T1DM for less than 1 year
- •Vitamin D sufficient (25-OH vit D level > 30 ng/mL)
- •Currently taking any medication that can interfere with vitamin D synthesis or metabolism, including but not limited to Orlistat, Phenobarbital, Dilantin, Anti-tuberculosis drugs
- •Currently taking any medication other than insulin that alters blood glucose levels, including but not limited to systemic glucocorticoids
- •Inadequate renal function (serum creatinine > 1.5mg/dL in males and > 1.2mg/dL in females) or inadequate liver function (AST and ALT > 2.5 times the upper limit of normal)
- •Evidence of malabsorption or short gut.
结局指标
主要结局
Hemoglobin A1c
时间窗: 6 months
The primary endpoint in this study will be the difference in change in Hemoglobin A1c between the treatment and non-treatment periods (6 months)
次要结局
- Pro-inflammatory markers(6 months)
- Vitamin D levels on insulin requirements(6 months)
- Vitamin D level and proinflammatory markers(6 months)
- Baseline differences between vitamin D deficient & sufficient subjects(Baseline)
- Vitamin D level and HbA1c(6 months)
研究者
Roshanak Monzavi MD
Assistant Professor, Center for Endocrinology, Diabetes, and Metabolism
Children's Hospital Los Angeles