Ignite Creation Date:
2024-05-06 @ 1:01 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03909659
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2019-03-31
Brief Title:
The Effects on Blood Pressure of Salt Substitute Among Adults With Hypertension in India
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
Official Title:
A Randomized-Controlled Trial to Determine the Effects on Blood Pressure of A Reduced-sodium Added-potassium Salt Substitute Among Adults With Hypertension in India
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Blood pressure is a key modifiable risk factor for cardiovascular disease in India Drug therapies are highly effective and are recommended by local guidelines to reduce the risks of serious cardiovascular complications Behavioural approaches to blood pressure control based upon sodium reduction are also recommended but there are no interventions proven effective in India
Mean sodium intake in India is about 5gday equivalent to about 125g salt which is more than double World Health Organization WHO recommendations Reduced sodium added potassium salt substitutes have favourable effects on blood pressure in settings where discretionary salt use is high but have not been tested in India This single-site Salt Substitute on blood pressure in India Study will investigate the effects of reduced sodium added potassium salt substitution on blood pressure in rural areas where hypertension is a prevalent disease problem and additional scalable and affordable interventions are required The primary objective is to assess the effects of salt substitute on SBP at 3 months follow-up The secondary objectives are to determine effects on DBP urinary sodium and potassium levels and to determine acceptability of the salt substitute
The study will be a double-blinded randomized-controlled trial done in the Hyderabad region amongst adult volunteers with a history of hypertension diagnosed by a health professional The main exclusion criteria will be known serous kidney disease or use of potassium containing medications by the individual or others living in the household Written informed consent will be obtained from potential participants followed by baseline data collection Eligible individuals will then be assigned at random to receive double-blind salt or salt substitute which will be used to replace all dietary salt used for cooking and seasoning over the next 3 months Follow-up will be at one and three months after randomisation for blood pressure urinary electrolytes and acceptability of the intervention
Mean sodium intake in India is about 5gday equivalent to about 125g salt which is more than double World Health Organization WHO recommendations Reduced sodium added potassium salt substitutes have favourable effects on blood pressure in settings where discretionary salt use is high but have not been tested in India This single-site Salt Substitute on blood pressure in India Study will investigate the effects of reduced sodium added potassium salt substitution on blood pressure in rural areas where hypertension is a prevalent disease problem and additional scalable and affordable interventions are required The primary objective is to assess the effects of salt substitute on SBP at 3 months follow-up The secondary objectives are to determine effects on DBP urinary sodium and potassium levels and to determine acceptability of the salt substitute
The study will be a double-blinded randomized-controlled trial done in the Hyderabad region amongst adult volunteers with a history of hypertension diagnosed by a health professional The main exclusion criteria will be known serous kidney disease or use of potassium containing medications by the individual or others living in the household Written informed consent will be obtained from potential participants followed by baseline data collection Eligible individuals will then be assigned at random to receive double-blind salt or salt substitute which will be used to replace all dietary salt used for cooking and seasoning over the next 3 months Follow-up will be at one and three months after randomisation for blood pressure urinary electrolytes and acceptability of the intervention
Detailed Description:
Excess sodium intake is associated with high blood pressure which is a leading risk for cardiovascular disease CVD in India Drug therapies are highly effective interventions for blood pressure lowering and are recommended by local guidelines to reduce the risks of serious cardiovascular complications Behavioural approaches to blood pressure control based upon sodium reduction are also recommended but there are no interventions proven effective and sustainable in India
Mean sodium intake in India is about 5gday equivalent to about 125g salt which is more than double World Health Organization WHO recommendations Reduced sodium added potassium salt substitutes have favourable effects on blood pressure in settings where discretionary salt use is high but have not been tested in India Salt substitution is of particular interest because it has great potential for scaling in under-served and resource poor settings
This study will investigate the effects of salt substitution on blood pressure in rural areas where hypertension is a highly prevalent disease problem and additional scalable and affordable blood pressure lowering interventions are required Accordingly the primary objective is to assess the effects of a reduced sodium added potassium salt substitute compared to usual salt on systolic blood pressure SBP at 3-months follow-up The secondary objectives are to determine effects on diastolic blood pressure DBP urinary sodium and potassium levels and to determine acceptability of the salt substitute among patients with hypertension
The study will be a double-blinded randomized-controlled trial done in the villages of the Hyderabad district amongst adult volunteers with a self-reported history of hypertension The main exclusion criteria will be known serous kidney disease or use of potassium containing medications by the individual or others living in the household Written informed consent will be obtained from potential participants followed by baseline data collection Eligible individuals will then be assigned at random to receive double-blind salt or salt substitute which will be used to replace all dietary salt required for cooking and seasoning in the household over the next 3-months Follow-up will be at one and three months after randomisation for assessment of blood pressure and acceptability of the intervention with urinary electrolytes measured at baseline and 3-months
The sample size will be 440 participants randomized in a 11 ratio to intervention or control which will provide more than 80 power P005 to detect a 5 mmHg or greater difference in SBP between randomized groups This estimate assumes a mean of 140mmHg and a standard deviation of 20mmHg for SBP at baseline We will seek to recruit comparable numbers of men and women Analyses will be done using the principle of intention-to-treat and a repeated measures analysis of variance that incorporates baseline 1-month and 3-month measures of SBP to maximize the efficiency of the analysis
Mean sodium intake in India is about 5gday equivalent to about 125g salt which is more than double World Health Organization WHO recommendations Reduced sodium added potassium salt substitutes have favourable effects on blood pressure in settings where discretionary salt use is high but have not been tested in India Salt substitution is of particular interest because it has great potential for scaling in under-served and resource poor settings
This study will investigate the effects of salt substitution on blood pressure in rural areas where hypertension is a highly prevalent disease problem and additional scalable and affordable blood pressure lowering interventions are required Accordingly the primary objective is to assess the effects of a reduced sodium added potassium salt substitute compared to usual salt on systolic blood pressure SBP at 3-months follow-up The secondary objectives are to determine effects on diastolic blood pressure DBP urinary sodium and potassium levels and to determine acceptability of the salt substitute among patients with hypertension
The study will be a double-blinded randomized-controlled trial done in the villages of the Hyderabad district amongst adult volunteers with a self-reported history of hypertension The main exclusion criteria will be known serous kidney disease or use of potassium containing medications by the individual or others living in the household Written informed consent will be obtained from potential participants followed by baseline data collection Eligible individuals will then be assigned at random to receive double-blind salt or salt substitute which will be used to replace all dietary salt required for cooking and seasoning in the household over the next 3-months Follow-up will be at one and three months after randomisation for assessment of blood pressure and acceptability of the intervention with urinary electrolytes measured at baseline and 3-months
The sample size will be 440 participants randomized in a 11 ratio to intervention or control which will provide more than 80 power P005 to detect a 5 mmHg or greater difference in SBP between randomized groups This estimate assumes a mean of 140mmHg and a standard deviation of 20mmHg for SBP at baseline We will seek to recruit comparable numbers of men and women Analyses will be done using the principle of intention-to-treat and a repeated measures analysis of variance that incorporates baseline 1-month and 3-month measures of SBP to maximize the efficiency of the analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None