A study to compare the efficacy of Telmisartan alone versus Telmisartan and Vitamin D supplementation on blood pressure in patients with stage I essential hypertension along with Vitamin D insufficiency Randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- mean reduction in systolic/diastolic blood pressure
研究概览
简要总结
In my study, patients attending outpatient department of General medicine, Victoria hospital BMCRI will be assessed for eligibility criteria, written informed consent will be taken, demographic data, medical history, physical and clinical examination and baseline investigations will be done
computer generated randomization will be done and participants will be assigned into two groups. Group A 42 participants on tablet Telmisartan 40 mg once daily and group B 42 participants on Telmisartan 40 mg once daily plus vitamin D 60,000 IU sachets once per week
Participants will be followed up at the end of 4 weeks and 8 weeks and measurement of systolic and diastolic BP will be done. Relevant statistical tests, compiling of data will be done and study will be terminated. Further treatment will be continued according to treating physician’s decision
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give written informed consent Patients of either sex aged above 18 years and less than 60 years Patients with newly diagnosed stage I essential hypertension as per JNC 8 guidelines BP more than 140 by 90 mmHg to less than 160 by 100 mmHg not on any antihypertensive medications Patients with vitamin D insufficiency 25 OH D levels of 20 to 29 ng per mL.
排除标准
- •Pregnant and lactating mothers Patients with secondary hypertension Patients with any other co-existing medical illness such as type 2 diabetes mellitus, dyslipidemia, cardiac, pulmonary, renal and hepatic disorders Patients who are on anticonvulsants, glucocorticoids, rifampicin, HAART therapy Patients with hypersensitivity to study medication.
结局指标
主要结局
mean reduction in systolic/diastolic blood pressure
时间窗: at baseline, 4 weeks, 8 weeks
次要结局
未报告次要终点
研究者
Dr Medhaveeni
Banglore medical college and research institute