Sodium-Potassium Blood Pressure Trial in Children

NCT ID: NCT00000521

Last Updated: 2014-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1985-08-31
• Study Completion Date: 1990-12-31

Brief Summary

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

Detailed 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.

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Interventions

diet, sodium-restricted

Intervention Type: BEHAVIORAL

diet, potassium-supplemented

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Gomez-Marin 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. doi: 10.1016/0197-2456(91)90020-m.

Reference Type: BACKGROUND

PMID: 1651211 (View on PubMed)

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. doi: 10.1161/01.hyp.21.6.989.

Reference Type: BACKGROUND

PMID: 8505112 (View on PubMed)

Other Identifiers

R01HL034659

Identifier Type: NIH

Identifier Source: secondary_id

View Link

40

Identifier Type: -

Identifier Source: org_study_id