The ECLA/PHRI Intervention in the Community Trial

NCT05638009 | Unknown DMC

• 1 other identifier: EPIC. Version 2.0
• Study Type: interventional
• Target: 2,490
• Locations: 1 country
• Sites: 1

Brief Summary

EPIC is a cluster-randomized, double-blind trial to evaluate the effect of two potassium-enriched salt substitute preparations (one available in the Argentine market and one derived from it), compared to regular salt on systolic blood pressure in subjects ≥ 18 and ≤ 90 years old from Rosario department households in Santa Fe Province, Argentina.

Conditions

Hypertension

Keywords

Sodium Chloride; Dietary

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure at day 120

  Systolic Blood Pressure will be measured by a standardized automated device

  120 days

Secondary Outcomes (4)

• Hyperkalemia

  120 days

• Salt substitutes acceptance and incorporation into the diet

  120 days

• Diastolic Blood Pressure at day 120

  120 days

• Mean arterial pressure (MAP) at day 120

  120 days

Study Arms (3)

Control

NO INTERVENTION

regular salt (99% sodium chloride)

Salt substitute 1

EXPERIMENTAL

Salt substitute 1 is a potassium-enriched salt substitute composed of 66% potassium chloride and 33% sodium chloride

Dietary Supplement: Salt substitute 66%33%

Salt substitute 2

EXPERIMENTAL

Salt substitute 2 is a potassium-enriched salt substitute composed of 33% potassium chloride and 66% sodium chloride

Dietary Supplement: Salt substitute 33%/66%

Interventions

Salt substitute 66%33% DIETARY_SUPPLEMENT

Salt substitute composed of 66% potassium chloride and 33% sodium chloride

Salt substitute 1

Salt substitute 33%/66% DIETARY_SUPPLEMENT

Salt substitute composed of 33% potassium chloride and 66% sodium chloride

Salt substitute 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ≥ 18 and ≤ 90 years old will be included, with no specific clinical conditions from households that meets the following criteria:
• The household must be composed of at least 2 individuals
• At least 1 of the individuals included must be over 40 years of age
• The household must be located in Rosario department, Santa Fe province, Argentina

You may not qualify if:

• Households will be excluded if a any household member has a at least one of the following contraindication to the salt substitute used in the trial:
• use of a potassium-sparing diuretic
• use of a potassium supplement
• known history of hyperkalemia
• use of salt reduced in sodium and enriched in potassium by medical indication
• do not consume any type of salt for medical indication
• known primary or secondary hyperaldosteronism
• known severe kidney disease (routine biochemical measurement of kidney function will not be performed in household members not included in the study).
• Pregnancy or lactation
• Evidence of hyperkalemia and/or a creatinine clearance (calculated through the CKD-EPI formula \<30 ml/min/1.73m2) in baseline blood laboratory. For those participants who consent to be tested, blood sample will be used. For those participant who has a laboratory test performed with those biomarkers in the past 6 months those results will be considered
• Households in which any of the study participants consume more than 50% of their meals prepared outside their home will also be excluded.

Sponsors & Collaborators

• Estudios Clínicos Latino América: lead
• Population Health Research Institute: collaborator

Study Sites (1)

IIC-Instituto de Investigaciones Clínicas

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• María Luz Diaz, MD

  ECLA- Estudios Clínicos Latino América

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Luz Diaz, MD

CONTACT

+54 9 341605-3295; marialuzdiaz02@gmail.com

Juan Manuel Dominguez, MD

CONTACT

+54 9 341210-6243; jdominguez@eclainternational.org

Study Design

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

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 6, 2022
• Study Start: November 14, 2022
• Primary Completion: April 14, 2023
• Study Completion: June 30, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

AR (1)