The Effect of Calcium-D Supplements on the Blood Pressure of Postmenopausal Women, Myth or Reality ? A Triple-blind Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 3
- 主要终点
- Mean diastolic blood pressure in 24 hours
研究概览
简要总结
Triple-blind randomized clinical trial was done on 98 hypertensive women of postmenopausal ages in 2019. The study was executed for 8 weeks with close follow up and , 24-hour Ambulatory blood pressure monitoring (ABPM) was used to record the initial and final blood pressures of all participants. Patients were randomized to calcium-D supplement and placebo
详细描述
Triple-blind randomized clinical trial were performed on 98 hypertensive women of postmenopausal ages in 2019. They were randomly divided into a control group of 50 members and a treatment group of 48 members. Randomization was based on block randomization method with block size=2 and ratio 2:2 for drug and placebo. To achieve triple blinding, patients were divided into "A" and "B" groups(by the mentioned randomization method). "A" was assigned to treatment and "B" to placebo but this assignment was not revealed to the patients, trial conductors and result assessors till the end of data analysis.
Oral calcium-D supplements were given to the treatment group in the form of tablets named Vana Flex® from Vana Darou Gostar Co. (VDG Co.). Each tablet contained 500 milligrams of calcium carbonate and 200 international units (IU) of vitamin D3(cholecalciferol). The placebo pills for the control group were chose in a way that looked similar to the calcium-D tablets in shape and color. The placebo tablets we used in this trial were made up of magnesium stearate 0.2 %, starch 10%, avicel 30%, and lactose 60%. The calcium-D and placebo tablets were both packed identically in order to assure blindness and the patients were told to take one tablet per day. The treatment and placebo group started drugs beside their previous hypertension medications.
24-hour Ambulatory blood pressure monitoring (ABPM) was done primarily for all of the participants to record the initial blood pressure of patients and after completion of study period
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Group A and group B
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal female with hypertension
- •receiving antihypertensive drugs
排除标准
- •history of coronary artery disease
- •congestive heart failure
- •chronic renal disease
- •hypercalcemia
- •nephrolithiasis
- •any other contraindications of calcium use
研究组 & 干预措施
treatment
patients received calcium D
干预措施: Calcium D (Drug)
control
patients received placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean diastolic blood pressure in 24 hours
时间窗: 60 days
24 hour holter monitoring was used to measure diastolic blood pressure in automated measurement for 80 times at home, in millimeter of mercury and device reported the mean of these diastolic pressures
Mean systolic blood pressure in 24 hours
时间窗: 60 days
24 hour holter monitoring was used to measure systolic blood pressure in automated measurement for 80 times at home, in millimeter of mercury and device reported the mean of these systolic pressures
Blood pressure dipping at night
时间窗: 60 days
24 hour holter monitoring was used to measure mean systolic blood pressure in automated measurement for 80 times at home, in millimeter of mercury and device reported the mean of these systolic pressures, and comparing mean of systolic blood pressure at night and day, and dippers are those who have more than 10% drop in mean systolic blood pressure at nigh
次要结局
- Effect of amlodipine on the effect of calcium-D supplements(60 days)
研究者
Javad Kojuri
professor
Shiraz University of Medical Sciences