NCT04894344: RCT

Education to Decrease in Sodium Intake Evaluated With 24 Hour Urinary Sodium Excretion (RCT)

Completed NA Last updated 2 January 2024

What this trial tests

NA trial testing Education group in Hypertension in 196 participants. Completed in 9 May 2023.

Timeline

28 October 2020

Primary endpoint
9 May 2023

9 May 2023

Quick facts

Lead sponsor	Universidad Autonoma de Baja California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	196
Start date	28 October 2020
Primary completion	9 May 2023
Estimated completion	9 May 2023
Sites	1 location across Mexico

Drugs / interventions tested

• Education group

Conditions studied

• Hypertension — all drugs for Hypertension →
• Overweight or Obesity — all drugs for Overweight or Obesity →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Universidad Autonoma de Baja California — full company profile →

Who can join

Adults 18 to 40, any sex, with Hypertension or Overweight or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

WHO identifies as an important risk factor and potentially modifiable to high sodium intake (\>2g/day 5g salt/day). Also, an insufficient consumption of potassium ( 3.5 g/day).Therefore, the results of this research could be the regional basis that is required to generate evidence, that designs strategies and recommendations for the prevention or decrease in the progression of high blood pressure. The reduction in the consumption of salt in the diet could comply with the recommendations established by international agencies. In addition, to favor the beginning of lifestyle changes, as well as other modifications that will have a positive impact on health.In population highly vulnerable to the campaigns of large industries that favor the consumption of processed food.

However, it is unknown what is the effect of reducing foods high in sodium in populations in different regions of Mexico, estimated by 24 hour urine sodium excretion.

Therefore, the present study aims to answer the following questions:

What impact does an intervention aimed at the decrease in sodium intake, in young university students on blood pressure and the quantification of the excretion of sodium and urinary potassium of 24h? What is the association between body mass index, blood pressure and sodium reduction in the intervention vs control group? To assess the impact of an intervention aimed at reducing sodium intake through education as general recommendations for limiting specific foods high in sodium, in university students on blood pressure and quantification of urinary sodium and potassium excretion of 24h.

Specific objectives Assess sodium intake between the intervention group and the control group by estimating 24-hour urinary sodium excretion.

secundary objectives Evaluate the effect between the intervention group and the control group on blood pressure.

To assess the levels of potassium excretion in the intervention and control groups.

To evaluate the association between body mass index, blood pressure and sodium reduction in the intervention and control groups.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.