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Sodium-Potassium Blood Pressure Trial in Children - Article


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Potassium Chloride Effervescent

Effer-K; Effervescent Potassium; Gen-K Powder; K+ Care; K-Lor Powder; K-Lyte; K-Lyte/Cl; Kay Ciel Powder; Klor-Con/EF; Klorvess 




Clinical Trial: Sodium-Potassium Blood Pressure Trial in Children

This study has been completed.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Purpose

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

Condition Treatment or Intervention Phase
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
 Behavior: diet, sodium-restricted
 Behavior: diet, potassium-supplemented
Phase III

MedlinePlus related topics:  Heart Diseases;   Heart Diseases--Prevention;   High Blood Pressure;   Vascular Diseases

Study Type: Interventional
Study Design: Prevention, Randomized

Further Study Details: 

Study start: August 1985

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.

Eligibility

Ages Eligible for Study:  10 Years   -   13 Years,  Genders Eligible for Study:  Both

Criteria

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

More Information

Publications

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.

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.

Study ID Numbers:  40
Record last reviewed:  January 2000
Last Updated:  October 13, 2004
Record first received:  October 27, 1999
ClinicalTrials.gov Identifier:  NCT00000521
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 28, 2009



Page Updated: June 1, 2005
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