Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women in Sub Saharan Africa
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in nycthemeral blood pressure profile (mmHg)
研究概览
简要总结
This study aims to determine the effect of calcium and vitamin D supplementation on oxidative status and blood pressure profile of postmenopausal patients with high blood pressure in Yaoundé, Cameroon.
This study is a double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital
详细描述
Aim: to determine and compare the short term effect of calcium and vitamin D supplementation on oxidative status and blood pressure profile of postmenopausal patients with high blood pressure in Yaoundé, Cameroon.
Method: A double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital. Postmenopausal hypertensive blacks women who are taking taking antihypertensives drugs since 12 months,without diabetes mellitus or any inflammatory disease or hypercalcemia, are randomize into 2 groups. Depending on the group, the intervention consisted of the administration of Calcium 1000 mg daily or Vitamin D/Calcium 1000 mg/800 UI daily for 08 weeks. The endpoints were the nycthemeral blood pressure profile, pro oxidant marker (malondialdehyde) and anti-oxidant marker (Ferric reducing antioxidant).
Progress: Recruitment for this study was completed in May 2019 with 22 patients.
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
- Double (Participant, Investigator)
盲法说明
The double-blind model is applied to the study. Only the adjudicator, responsible for the distribution of medication knew the different regimes. Calcium and Vitamin D/Calcium were packaged in boxes of identical appearance and labeled for each participant by name and number of the randomization program. The randomization and packaging of the drugs was done by an investigator who had no clinical involvement.
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post menopausal hypertensive women since 12 months
- •On a stable antihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes.
- •Before any study-specific procedure, the appropriate written informed consent must be obtained.
排除标准
- •Diabetes mellitus or inflammatory diseases
- •Hypercalcemia,
- •Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
- •Withdrawal of consent
研究组 & 干预措施
Calcium arm
1000 mg Calcium tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.
干预措施: Calcium Arm (Dietary Supplement)
Vitamin D/Calcium
1000 mg/800UI of VitaminD/Calcium tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.
干预措施: Vitamin D/Calcium (Dietary Supplement)
结局指标
主要结局
Change in nycthemeral blood pressure profile (mmHg)
时间窗: 8 weeks
Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.
次要结局
- Change in serum concentration of oxidant marker: malondialdehyde (micromol/l)(8 weeks)
研究者
CN NGANOU-GNINDJIO, MD, MSc
Dr, Principal investigator
Yaounde Central Hospital