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Sodium-Potassium Blood Pressure Trial in Children

Sodium-Potassium Blood Pressure Trial in Children

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000521
Enrollment
285
Registered
1999-10-28
Start date
1985-08-31
Completion date
1990-12-31
Last updated
2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

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.

Interventions

BEHAVIORALdiet, potassium-supplemented

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 13 Years
Healthy volunteers
No

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026