Sodium-Potassium Blood Pressure Trial in Children

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University of Minnesota (UMN)

Status and phase

Completed
Phase 4

Conditions

Hypertension
Cardiovascular Diseases
Vascular Diseases
Heart Diseases

Treatments

Behavioral: diet, potassium-supplemented
Behavioral: diet, sodium-restricted

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00000521
40
R01HL034659 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

285 patients

Sex

All

Ages

10 to 13 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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