Effect of Dietary Salt Reduction and Low Sodium Salt Substitution on Blood Pressure among Hypertensive Adults Attending Urban Primary Care Facilities in Hyderabad A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 195
- 试验地点
- 1
研究概览
简要总结
This study is a randomized parallel group controlled clinical trial designed to evaluate and compare the effects of two different dietary interventions on blood pressure among adults with hypertension attending urban primary care clinics in Hyderabad Telangana India. A total of 195 participants will be randomly allocated into three groups including a control group receiving standard dietary advice a structured salt reduction group and a low sodium salt substitute group. The intervention period will be one month . The salt reduction group will receive pre measured household salt quantities along with structured dietary counselling based on behaviour change principles . The low sodium salt substitute group will receive a salt substitute containing reduced sodium and increased potassium after baseline safety screening .
The primary outcome is change in systolic blood pressure from baseline to one month . Secondary outcomes include change in diastolic blood pressure urinary sodium and potassium excretion sodium potassium ratio and adherence to the intervention . The study will provide evidence on the effectiveness and feasibility of these household level sodium reduction strategies in urban care settings .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 years and above Clinical diagnosis of hypertension with or without antihypertensive medication Systolic blood pressure 140 millimetres of mercury or higher and or diastolic blood pressure 90 millimetres of mercury or higher at screening Primarily consume home cooked meals defined as at least two major meals cooked at home on most days of the month Willing and able to provide written informed consent.
排除标准
- •Use of potassium sparing diuretics Current potassium supplementation Known history of acute or chronic kidney disease Baseline hyperkalemia Pregnant or lactating women Households with children below five years of age Current use of low sodium salt substitute Any medical condition considered unsafe for participation by the study medical officer Participants planning to relocate from the study area during the trial period.
研究者
BIDUSHI BISWAS
ICMR- NATIONAL INSTITUTE OF NUTRITION (NIN)