NCT02016404

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
Last Updated

December 20, 2013

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

December 9, 2013

Last Update Submit

December 13, 2013

Conditions

Hypertension

Keywords

blood pressuresodiumsaltlow sodium high potassium saltpotassiumVietnamrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in office diastolic blood pressure (DBP)

    Change during 8 weeks of intervention

Other Outcomes (8)

  • 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

  • +5 more other outcomes

Study Arms (2)

Low-sodium, high-potassium salt

ACTIVE COMPARATOR

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

Regular salt

PLACEBO COMPARATOR

Regular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt

Other: Regular salt

Interventions

Low-sodium, high-potassium saltOTHER

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

Low-sodium, high-potassium salt
Regular saltOTHER

Regular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt

Regular salt

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Nutrition (NIN), Department of Community Nutrition

Hanoi, Hai Ba Trung Dist., Vietnam

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Ha TP Do

    Community Nutrition, National Institute of Nutrition, Vietnam

    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

December 9, 2013

First Posted

December 20, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 20, 2013

Record last verified: 2013-12

Locations

VN(1)