| CTRI Number |
CTRI/2024/04/066531 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The Impact of Salt Substitutes on Blood Pressure among Hypertensive Urban Slum Residents of Hyderabad, Telangana |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
LSSS-BD Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C S Surya Goud |
| Designation |
Scientist-B(Medical) |
| Affiliation |
ICMR-NATIONAL INSTITUTE OF NUTRITION |
| Address |
Room no: 101, Division of Public Health Nutrition.
Gopalan Block,
ICMR-NATIONAL INSTITUTE OF NUTRITION
Hyderabad
TELANGANA
500007
India |
| Phone |
9581515390 |
| Fax |
|
| Email |
suryachuka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C S Surya Goud |
| Designation |
Scientist-B(Medical) |
| Affiliation |
ICMR-NATIONAL INSTITUTE OF NUTRITION |
| Address |
Room no: 101, Division of Public Health Nutrition.
Gopalan Block,
ICMR-NATIONAL INSTITUTE OF NUTRITION
Hyderabad
TELANGANA
500007
India |
| Phone |
9581515390 |
| Fax |
|
| Email |
suryachuka@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C S Surya Goud |
| Designation |
Scientist-B(Medical) |
| Affiliation |
ICMR-NATIONAL INSTITUTE OF NUTRITION |
| Address |
Room no: 101, Division of Public Health Nutrition.
Gopalan Block,
ICMR-NATIONAL INSTITUTE OF NUTRITION
Hyderabad
TELANGANA
500007
India |
| Phone |
9581515390 |
| Fax |
|
| Email |
suryachuka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Global Non-profit organization-Resolve to Save Lives, 100 Broadway, 4th Floor New York, NY, 10005 United States |
|
|
Primary Sponsor
|
| Name |
Resolve to Save Lives |
| Address |
100 Broadway, 4th Floor
New York, NY, 10005
United States |
| Type of Sponsor |
Other [Global Non-profit organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C S Surya Goud |
ICMR-National Institute of Nutrition |
Room no: 101, Division of Public Health Nutrition.
Gopalan Block.
Hyderabad
TELANGANA |
9581515390
suryachuka@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICMR NIN- Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, (3) ICD-10 Condition: I15||Secondary hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I.Reduced-sodium, added-potassium salt substitute (70% sodium chloride/ 30 % potassium chloride blend). |
The sodium reduction intervention is based upon the provision of reduced-sodium, added-potassium salt substitute (70% sodium chloride/ 30 % potassium chloride blend). Participants will be advised to replace all discretionary salt use with the salt substitute. |
| Intervention |
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, added-potassium salt substitute (85% sodium chloride/ 15 % potassium chloride blend). Participants will be advised to replace all discretionary salt use with the salt substitute. |
| Comparator Agent |
Regular Salt |
Regular salt (100% sodium chloride) will be provided to participants in the control group, who will be advised to replace discretionary salt use at home with the salt provided. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-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. |
|
| ExclusionCriteria |
| Details |
- 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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The mean change in systolic and diastolic blood pressures among Intervention
Group –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. |
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 Outcome
|
| Outcome |
TimePoints |
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. |
Monthly intervals i.e., from 1 to 6 months; and at 12
months from baseline as compared to the control arm will be calculated. |
|
|
Target Sample Size
|
Total Sample Size="750"
Sample Size from India="750"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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.
|