Long-Term Outcomes of Low Sodium Salt Substitutes (Reduced Sodium Added Potassium) on Blood Pressure among Hypertensive Urban Slum Population in Telangana: A Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Resolve to Save Lives
- Enrollment
- 750
- Locations
- 1
- Primary Endpoint
- The mean change in systolic and diastolic blood pressures among Intervention
Overview
Brief Summary
Title: Long-Term Outcomes of Low Sodium Salt Substitutes (Reduced Sodium Added Potassium) on Blood Pressure among Hypertensive Urban Slum Population in Telangana: A Randomized Controlled Trial
Background:
Hypertension poses a significant global health challenge, especially in countries like India, where its prevalence is high and control rates remain low. With lifestyle factors and an ageing demographic exacerbating the problem, effective strategies for managing hypertension are need of hour. In this context, low-sodium salt substitutes (LSSS) have garnered attention as a promising intervention due to their potential to effectively lower blood pressure levels
Purpose of the Trial:
The trial aims to investigate the long-term effects of LSSS on blood pressure among hypertensive individuals living in the urban slums of Hyderabad, Telangana. By conducting a randomized controlled trial, the study seeks to evaluate the efficacy, safety, and acceptability of LSSS in this population. Additionally, the trial aims to assess the feasibility of scaling up the intervention in community settings. Overall, the trial seeks to provide valuable insights into the effectiveness of LSSS as a dietary intervention for hypertension management in Urban Slum settings.
Objectives:
Primary:
• To assess the long-term effects of low-sodium salt substitutes (30% potassium replacement) on blood pressure among the hypertensive urban slum population in Telangana.
Secondary:
• To evaluate the effects of low-sodium salt substitutes with a lower percentage of potassium replacement (15%).
• To assess changes in blood pressure among household members over the intervention period.
• To evaluate the acceptability and potential side effects of LSSS.
• To examine cultural aspects, knowledge, and practices related to dietary salt.
• To assess the feasibility of scaling up the intervention in a larger community trial.
Methodology:
The study will be a double-blinded, placebo-controlled randomized controlled trial conducted in the urban slums of Hyderabad. Sample size estimation accounts for attrition rates. Known and newly diagnosed hypertensive subjects will be enrolled and randomly assigned to intervention arms receiving different salt substitutes. Monthly follow-ups will assess outcomes including blood pressure, urinary electrolytes and acceptability.
Ethical Issues:
The study will obtain necessary approvals and informed consent from participants and households. Newly diagnosed hypertensive individuals will be referred for further medical care.
Data Analysis Plan:
Data will be collected, anonymized, and analyzed using appropriate statistical methods to evaluate efficacy, safety, and acceptability outcomes.
Expected Outcomes:
The study will demonstrate the efficacy, safety, and acceptability of LSSS in reducing blood pressure among hypertensive individuals. Findings will inform the feasibility of scaling up interventions in community settings.
Timeline:
The study will be conducted over 18 months, including recruitment, baseline data collection, follow-ups, and data analysis.
Limitations:
The study acknowledges limitations such as convenience sampling, the potential increase in overall salt intake among participants, and the use of spot urine analysis instead of 24-hour urine collection.
Future Plans:
Based on study findings, scaled-up community trials may be planned, extending interventions to rural areas.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female aged 18 years or over. -History of hypertension diagnosed by health professional–antihypertensive drugs may or may not be used for management.
- •Eat most of their meals in/from the home i.e., at least 2 major meals are cooked from home for at least 25 days a month.
- •Consent to participate.
Exclusion Criteria
- •They or any other household members are using a potassium-sparing diuretic, but not if they use other hypertensive medications.
- •They or any other household members used potassium supplements, had any known acute or chronic kidney diseases,.
- •Households having children under 5 years of age, pregnant or lactating women (owing to data gap on safety in children).
- •They have any other reason for concern about use of salt substitute,.
- •Subjects who are not expected to stay in that area for 12 months from the date of initiation of the trial.
- •Subjects who are already using LSSS salt.
Outcomes
Primary Outcomes
The mean change in systolic and diastolic blood pressures among Intervention
Time Frame: Monthly intervals i.e., from 1 to 6 months; and at 12 | months from baseline as compared to the control arm and 15% arm will be calculated.
Group –I (enrolled subject and household members) at monthly intervals (1 to 6 months; and at 12
Time Frame: Monthly intervals i.e., from 1 to 6 months; and at 12 | months from baseline as compared to the control arm and 15% arm will be calculated.
months) from baseline as compared to the control arm and 15% arm will be calculated.
Time Frame: Monthly intervals i.e., from 1 to 6 months; and at 12 | months from baseline as compared to the control arm and 15% arm will be calculated.
Secondary Outcomes
- The mean change in systolic and diastolic blood pressures among Intervention(Group –II 15% arm (enrolled subject and household members) at monthly intervals (1 to 6 months; and at 12 months) from baseline as compared to the control arm will be calculated.)
Investigators
Dr C S Surya Goud
ICMR-NATIONAL INSTITUTE OF NUTRITION