Sodium in adults and Adolescents Lowering Trial: the SALT trial

Phase 1

• Conditions: Circulatory System; Nutritional, Metabolic, Endocrine

• Registration Number: PACTR202306727520808
• Lead Sponsor: MRC Wits Developmental Pathways for Health Research Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-09
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. Male/Female.
2. African descent living in Soweto.
3. Adolescents, aged 13-19 years, primary caregiver (parent/guardian) and where the primary caregiver is <40 years of age, also a member of the household (aged 40-70 years).
4. Eats in the home a minimum of five days a week.
5. Stays in the home a minimum of five days a week.
6. Individuals presenting with new clinical hypertension (will be referred).
7. Use of ACE inhibitors or Angiotensin receptor blockers (participant will be flagged for monitoring.

Exclusion Criteria

1. Inability to read or understand English.
2. Self-reported previous diagnosis of kidney disease/diminished kidney function (any household member regardless of participation).
3. Urine dipstick indicating potential kidney disease/diminished kidney function as indicated by proteinurea (any household member regardless of participation).
4. Estimated Glomerular Filtration Rate below 60 mL/min (any household member over 20 years of age regardless of participation).
5. Use of Potassium-sparing diuretics (any household member regardless of participation).
6. Potential contraindication to the potassium-enriched salt (any household member regardless of participation).
7. Considered to eat most meals outside of the home.
8. Previous diagnosis or currently self-reporting any eating disorder.
9. Participating in any other trial.
10. Households without cooking facilities.
11. High-level athletes.
12. Self-reported pregnancy at time of screening (any household member regardless of participation).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In adolescents and adults: Difference in change in spot urinary sodium-to-potassium molar ratio from baseline to 16 weeks.;In adults: Difference in change in systolic BP from baseline to 16 weeks.

Secondary Outcome Measures

Name	Time	Method
In adolescents: Difference in change in systolic and diastolic BP from baseline to 16 weeks.;In adults: Difference in change in diastolic BP and spot urinary sodium-to-potassium molar ratio from baseline to 16 weeks.