Effect of vitamin D supplementation on serum levels of cortisol, estrogen and testosterone in patients of primary open angle glaucoma
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. To study the effect of vit D supplementation on serum cortisol levels in patients of POAG
研究概览
简要总结
This is a prospective, randomized, double blinded, and parallel group study aimed at investigating the effect of Vitamin D supplementation on serum levels of cortisol, estrogen, and testosterone in patients of primary open angle glaucoma (POAG). It will be conducted in the Institute of Ophthalmology JNMCH, AMU, Aligarh, India.
The intervention/study group will be administered 60,000 IU of Vitamin D3, once weekly, for a period of 12 weeks. At the end of supplementation serum levels of hormones and effect on IOP on study and control groups will be analysed.
The primary objective is to study the effect of Vitamin D supplementation on the serum levels of cortisol, estrogen and testosterone in patients of POAG.
The secondary objectives are to study the effect of Vitamin D supplementation on control of intraocular pressure and to compare the levels of serum cortisol, estrogen, testosterone between diabetic and non-diabetic patients of POAG.
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
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of Primary open angle glaucoma.
排除标准
- •Patients receiving vit D and calcium supplements
- •Patients taking any other medication that could change vit D metabolism such as Phenytoin or Rifampin
- •Patients taking any medication that could change cortisol metabolism such as steroids, ketoconazole or mitotane.
- •Patients taking Hormone Replacement Therapy 5.
结局指标
主要结局
1. To study the effect of vit D supplementation on serum cortisol levels in patients of POAG
时间窗: 12 weeks
2. To study the effect of vit D supplementation on serum estrogen levels in patients of POAG
时间窗: 12 weeks
3. To study the effect of vit D supplementation on serum testosterone levels in patients of POAG
时间窗: 12 weeks
次要结局
- 1. To study the effect of vit D supplementation on control of intraocular pressure in patients of POAG(2. To compare the levels of serum cortisol in diabetic and non-diabetic patients of POAG)
研究者
Prof. Simi Zaka-ur-Rab
Institute of Ophthalmology,Jawaharlal Nehru Medical College and hospital, Aligarh Muslim University