Effect of vitamin D supplementation on serum levels of pigment epithelium derived factors and vascular endothelium growth factors in patients of Diabetic Retinopathy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- serum levels of vascular endothelial growth factor and pigment epithelial derived growth factor after vitamin D supplementation
研究概览
简要总结
This is a Randomized triple blinded parallel group study to determine the effect of Vitamin D3 supplementation on the serum levels of vascular endothelial growth factor and pigment epithelial derived factor in patients of Diabetic retinopathy for a period of 12 weeks in 120 patients that will be conducted at one center in India. the primary outcomes measures will be serum levels of vascular endothelial growth factor and pigment epithelial derived factor after vitamin D supplementation. the secondary outcomes will be serum levels of methylglyoxal in various grades of diabetic retinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Non Proliferative and Proliferative Diabetic Retinopathy.
排除标准
- •Patients receiving vitamin D and calcium supplements.
- •Patients taking any other medication that could change vitamin D metabolism, such as Rifampicin or Phenytoin.
- •Patients with very low vitamin D / sufficient vitamin levels iv.
- •patients who have recieved injection antiVEGF for past 3 months v.
- •patients who have recieved laser in retina for past 1 month.
结局指标
主要结局
serum levels of vascular endothelial growth factor and pigment epithelial derived growth factor after vitamin D supplementation
时间窗: 12 weeks
次要结局
- serum levels of vascular endothelial growth factor and pigment epithelial derived growth factor in various grades of diabetic retinopathy(12 weeks)
研究者
Prof SIMI ZAKAURRAB
AMUIO, JNMCH, AMU, Aligarh