Sodium-Potassium Blood Pressure Trial in Children
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Hypertension
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
diet, sodium-restricted
diet, potassium-supplemented
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
Children in grades 5 through 8 whose systolic blood pressure was greater than or equal to 120 mm Hg on two visits.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000521
First Posted
October 27, 1999
Last Updated
May 27, 2014
Sponsor
University of Minnesota
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000521
Brief Title
Sodium-Potassium Blood Pressure Trial in Children
Official Title
Sodium-Potassium Blood Pressure Trial in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 1985 (undefined)
Primary Completion Date
July 1990 (Actual)
Study Completion Date
December 1990 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
diet, sodium-restricted
Intervention Type
Behavioral
Intervention Name(s)
diet, potassium-supplemented
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Children in grades 5 through 8 whose systolic blood pressure was greater than or equal to 120 mm Hg on two visits.
12. IPD Sharing Statement
Citations:
PubMed Identifier
1651211
Citation
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.
Results Reference
background
PubMed Identifier
8505112
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. doi: 10.1161/01.hyp.21.6.989.
Results Reference
background
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Sodium-Potassium Blood Pressure Trial in Children
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