NCT00000521

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P50-P75 for phase_4 cardiovascular-diseases

Timeline
Completed

Started Aug 1985

Longer than P75 for phase_4 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1985

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 1990

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1990

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

4.9 years

First QC Date

October 27, 1999

Last Update Submit

May 27, 2014

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionVascular Diseases

Interventions

diet, sodium-restrictedBEHAVIORAL
diet, potassium-supplementedBEHAVIORAL

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Children in grades 5 through 8 whose systolic blood pressure was greater than or equal to 120 mm Hg on two visits.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 1651211BACKGROUND

  • 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.

    PMID: 8505112BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionVascular Diseases

Interventions

Diet, Sodium-RestrictedDiet

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

August 1, 1985

Primary Completion

July 1, 1990

Study Completion

December 1, 1990

Last Updated

May 29, 2014

Record last verified: 2014-05