The Relationship of Vitamin D and Irisin With Blood Pressure and Heart Rate Variability in Normotensive and Hypertensive Individuals: The Impact of Vitamin D Supplementation in Hypertensive Vitamin D Deficient Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Systolic Blood pressure
研究概览
简要总结
This study will assess the impact of Vitamin D supplementation on hypertensive patients with Vitamin D deficiency, it will also investigate the relationship between serum Vitamin D, irisin levels, blood pressure, and heart rate variability (HRV) in hypertensive and normotensive individuals.
It is hypothesized that a decrease in blood pressure and an increase in HRV will be noted in the hypertensive treatment group (subjects on supplemental vitamin D) in comparison to the hypertensive control group (placebo) upon vitamin D supplementation.
详细描述
In a prospective study conducted on 160 participants, 80 hypertensive and 80 normotensive individuals, assessing correlations between Vitamin D, irisin, blood pressure, and HRV, hypertensive vitamin D deficient participants will be recruited in a randomized controlled trial. In this clinical trial, 60 hypertensive participants with Vitamin D deficiency will receive either Vitamin D supplementation (25,000 IU weekly) or a placebo for 8 weeks (30 participants in each group).
Outcome measures include systolic and diastolic blood pressure, HRV, serum Vitamin D, and serum irisin levels before and after supplementation.
The aim is to explore the potential role of Vitamin D and irisin in regulating blood pressure and improving HRV, potentially offering preventive measures for hypertension management.
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)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hypertensive: Adult individual diagnosed with hypertension by a specialist (at least two systolic blood pressure readings above 140 mmHg or diastolic blood pressure readings above 90 mmHg, measured by a qualified professional following American Heart Association guidelines) managing hypertension through medication adherence, and regularly attending heart clinic appointments, with no other systemic diseases.
- •Control: Healthy adult individuals without hypertension or a history of other systemic diseases who volunteer and participate in the study, which will be recruited from relatives, friends, colleagues or patient accompanies. - (*Note: The healthy participants were included in the first part of the study before starting the clinical trial)
排除标准
- •Hypertensive individuals who have heart failure and other cardiac or systemic diseases or with recent cardiovascular events.
- •Secondary hypertension
- •Hypertensive patients who require medication change during the course of the study.
- •Individuals on Lipid-lowering agents (e.g. simvastatin).
- •The use of other medications affecting blood pressure is not part of the study protocol.
- •Any subjects on regular supplemental vitamin D or receiving multi-vitamins regularly with vitamin D content of more than 880 IU, one month before recruitment.
- •Individuals with a BMI over 35 or less than 18 kg/m
- •Subjects with a significant change in lifestyle, for example, exercise, weight change, or on a specific dietary regimen during or in the previous four weeks of the study.
- •Subject diagnosed with neoplasm, or inflammatory or autoimmune diseases
- •Pregnant or lactating female
结局指标
主要结局
Systolic Blood pressure
时间窗: 10 weeks
This measure will track mean changes in systolic blood pressure in mmHg, before and after 8 weeks of Vitamin D supplementation. The objective is to observe whether there is a significant decrease in systolic blood pressure in hypertensive patients receiving Vitamin D compared to those receiving a placebo.
Diastolic Blood pressure
时间窗: 10 weeks
This measure will assess mean changes in diastolic blood pressure in mmHg, before and after 8 weeks of Vitamin D supplementation. The study aims to determine if there is a significant decrease in diastolic blood pressure in hypertensive patients receiving Vitamin D compared to the placebo group.
Heart rate variability (HRV)
时间窗: 10 weeks
It includes the time domain in milliseconds-ms and frequency domains
次要结局
- Serum Irisin(10 weeks)
- Serum hydroxycholecalciferol(10 weeks)
研究者
Darya Saeed Abdulateef
Assistant Professor
University of Sulaimani