The Effects on Blood Pressure of Salt Substitute Among Adults With Hypertension in India

NCT03909659 | Completed

• 1 other identifier: SSiIS
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

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 5g/day (equivalent to about 12.5g 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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  As measured by using an automated blood pressure monitor according to established standardized methods.

  three months

Secondary Outcomes (4)

• Diastolic Blood Pressure

  three months

• Urinary sodium excretion

  three months

• Urinary potassium excretion

  three months

• Acceptability of the study salt substitute

  three months

Study Arms (2)

Control

NO INTERVENTION

Normal salt

Reduced-sodium added-potassium salt substitute

EXPERIMENTAL

salt substitute

Behavioral: Dietary sodium reduction

Interventions

Dietary sodium reduction BEHAVIORAL

A supply of a reduced-sodium added-potassium salt substitute

Reduced-sodium added-potassium salt substitute

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 years or over
• History of hypertension diagnosed by a health professional - hypertension may be self-reported and antihypertensive drugs may or may not be used for management. There is no entry criterion based upon blood pressure measurements made at the baseline survey
• Eat most of their meals in the home
• Consent to participate

You may not qualify if:

• Participant or family member is using a potassium-sparing diuretic
• Participant or family member is using a potassium supplement
• Participant or family member has known significant renal dysfunction
• Participant or family member has other reason for concern about use of salt substitute
• Participant is not expected to live longer than 6 months from the date of assessment
• Another member of the household is already enrolled in the study

Sponsors & Collaborators

• The George Institute: lead

Study Sites (1)

The George Institute for Glaobal Health India

New Delhi, 110025, India

Location

Related Publications (1)

• Yu J, Thout SR, Li Q, Tian M, Marklund M, Arnott C, Huffman MD, Praveen D, Johnson C, Huang L, Pettigrew S, Neal B, Wu JHY. Effects of a reduced-sodium added-potassium salt substitute on blood pressure in rural Indian hypertensive patients: a randomized, double-blind, controlled trial. Am J Clin Nutr. 2021 Jul 1;114(1):185-193. doi: 10.1093/ajcn/nqab054.

  PMID: 33782684 DERIVED

Study Officials

• Jie Yu

  The George Institute

  PRINCIPAL INVESTIGATOR

• Thout Sudhir Raj

  The George Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 10, 2019
• Study Start: November 25, 2019
• Primary Completion: May 30, 2020
• Study Completion: November 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)