Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000521
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
1999-10-27
Brief Title:
Sodium-Potassium Blood Pressure Trial in Children
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Sodium-Potassium Blood Pressure Trial in Children
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 19542 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 mmolkg 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
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 19542 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 mmolkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL034659 | NIH | None | httpsreporternihgovquickSearchR01HL034659 |