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The Impact of Salt Substitutes on Blood Pressure among Hypertensive Urban Slum Residents of Hyderabad, Telangana

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 - LSSS-BD Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066531
Enrollment
750
Registered
2024-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: I119- Hypertensive heart disease withoutheart failure Health Condition 3: I15- Secondary hypertension

Interventions

Intervention1: II.Reduced-sodium, added-potassium salt substitute (85% sodium chloride/ 15 % potassium chloride blend).: The sodium reduction intervention is based upon the provision of reduced-sodium

Sponsors

Resolve to Save Lives
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Male or female aged 18 years or over. -History of hypertension diagnosed by health professionalâ??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

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.

Design outcomes

Primary

MeasureTime frame
The mean change in systolic and diastolic blood pressures among Intervention Group â??I (enrolled subject and household members) at monthly intervals (1 to 6 months; and at 12 months) from baseline as compared to the control arm and 15% arm will be calculated.Timepoint: 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

MeasureTime frame
The mean change in systolic and diastolic blood pressures among Intervention Group â??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.Timepoint: Monthly intervals i.e., from 1 to 6 months; and at 12 months from baseline as compared to the control arm will be calculated.

Countries

India

Contacts

Public ContactDr C S Surya Goud

ICMR-NATIONAL INSTITUTE OF NUTRITION

suryachuka@gmail.com9581515390

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026