The Effect of a Low Sodium-High Potassium Salt on Blood Pressure in Vietnamese Adults

The purpose of this study was to investigate the effects of low-sodium, high-potassium condiments and salt on blood pressure in untreated (pre)hypertensive Vietnamese adults.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Low-sodium, high-potassium salt; Other: Regular salt

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hai Ba Trung dist.
    • Hanoi, Hai Ba Trung dist., Vietnam
      • National Institute of Nutrition (NIN), Department of Community Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Untreated prehypertension or mild hypertension (systolic BP between 130 and 160 mmHg and/or diastolic BP between 85 and 100 mmHg) based on the mean of two measurements with a 1-week interval

Exclusion Criteria:

Diagnosed or self-reported cardiovascular disease Diagnosed or self-reported kidney disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-sodium, high-potassium salt; Iodized low-sodium, high-potassium botcanh (a traditional mixture of salt, mono sodium glutamate (MSG), sugar and herbs) plus and iodized low-sodium, high-potassium salt for home food preparation	Other: Low-sodium, high-potassium salt; Iodized low-sodium, high-potassium botcanh (a traditional mixture of salt, MSG, sugar and herbs) plus and iodized low-sodium, high-potassium salt for home food preparation
Placebo Comparator: Regular salt; Regular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt	Other: Regular salt; Regular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in office systolic blood pressure (SBP)	Based on repeated measurements with a digital BP device (OMRONHEM 762) using the standard protocol of WHO STEP guideline at week 0, 2, 4 6 and 8.	Change during 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in office diastolic blood pressure (DBP)	Based on repeated measurements with a digital BP device (OMRONHEM 762) using the standard protocol of WHO STEP guideline at week 0, 2, 4, 6 and 8.	Change during 8 weeks of intervention

Other Outcome Measures

Outcome Measure	Time Frame
Change in 24-hour urinary sodium excretion	Change during 8 weeks of intervention
Change in 24-hour urinary potassium excretion	Change during 8 weeks of intervention
Change in body weight	Change during 8 weeks of intervention
Change in 24-hour urinary calcium excretion	Change during 8 weeks of intervention
Change in 24-hour urinary iodine excretion	Change during 8 weeks of intervention
Change in 24-hour urinary creatinine excretion	Change during 8 weeks of intervention
Change in 24-hour urinary protein	Change during 8 weeks of intervention
Change in heart rate	Change during 8 weeks of intervention

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: National Institute of Nutrition, Vietnam
• Investigators: Principal Investigator: Ha TP Do, Community Nutrition, National Institute of Nutrition, Vietnam

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 20, 2013

Study Record Updates

• Last Update Posted (Estimate): December 20, 2013
• Last Update Submitted That Met QC Criteria: December 13, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: randomized controlled trial; blood pressure; potassium; Vietnam; sodium; salt; low sodium high potassium salt
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 0793