Sodium-Potassium Blood Pressure Trial in Children

Hypertension Clinical Trial

Official title:

Sodium-Potassium Blood Pressure Trial in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000521
• Other study ID #: 40
• Secondary ID: R01HL034659
• Status: Completed
• Phase: Phase 4
• First received: October 27, 1999
• Last updated: May 27, 2014
• Start date: August 1985
• Est. completion date: December 1990

Study information

• Verified date: May 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

To examine the effects of nutritional intervention on the rate of rise of blood pressure in late childhood and early adolescence.

Description:

BACKGROUND:

Since 1970, children and adolescents with hypertension have been detected with increasing frequency. Many of them were thought to have primary or essential hypertension and it remained unclear how they should be managed. Additionally, since tracking of blood pressure occurred even in early life, it was believed that youngsters with blood pressures persistently in the upper deciles for age were at increased risk for later hypertension. No clinical trials had been performed in this age group to examine the effects of non-pharmacologic or drug therapy in lowering blood pressure. The trial was one of the first attempts to examine the effects of a nutritional intervention on the rate of rise of blood pressure in late childhood and early adolescence.

DESIGN NARRATIVE:

Randomized, partial-blind. After 19,542 fifth to eighth grade students were screened, 210 (105 boys and 105 girls) from the upper 15 percentiles of blood pressure distribution were randomly assigned to one of three groups: low sodium diet (70 mmol sodium intake per day), potassium chloride supplementation (normal diet plus 1 mmol/kg potassium chloride per day), and placebo (normal diet plus placebo capsule). Capsules for the potassium chloride and placebo groups were administered in a double blind protocol. Blood pressure was measured every three months for three years. The effect of the intervention was determined by comparing the rate of rise (slope) of blood pressure among the groups using a random-coefficient growth curve model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: December 1990
• Est. primary completion date: July 1990
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 13 Years

Eligibility

Children in grades 5 through 8 whose systolic blood pressure was greater than or equal to 120 mm Hg on two visits.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Hypertension
• Vascular Diseases

Intervention

Behavioral:
• diet, sodium-restricted

• diet, potassium-supplemented

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

Gómez-Marín O, Prineas RJ, Sinaiko AR. The Sodium-Potassium Blood Pressure Trial in Children. Design, recruitment, and randomization: the children and adolescent blood pressure program. Control Clin Trials. 1991 Jun;12(3):408-23. — View Citation

Sinaiko AR, Gomez-Marin O, Prineas RJ. Effect of low sodium diet or potassium supplementation on adolescent blood pressure. Hypertension. 1993 Jun;21(6 Pt 2):989-94. — View Citation