NCT00581373

Brief Summary

We will test the null hypothesis that there is no diurnal (morning to afternoon)variability in the blood pressure response to the ingestion of water 16 oz.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
43mo left

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress84%
Aug 2007Dec 2029

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
21.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

22.4 years

First QC Date

December 22, 2007

Last Update Submit

October 8, 2025

Conditions

Orthostatic Hypotension

Keywords

waterorthostatic hypotensionblood pressure

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    peak systolic blood pressure within 60 min of ingestion

    1 day

Secondary Outcomes (1)

  • heart rate

    1 day

Study Arms (1)

1

EXPERIMENTAL

water 16 oz

Other: water 16 fl oz

Interventions

water 16 fl ozOTHER

water 16 fl oz in AM and repeat in late afternoon

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • orthostatic intolerance

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Links

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Satish R Raj, MD MSCI

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine & Pharmacology

Study Record Dates

First Submitted

December 22, 2007

First Posted

December 27, 2007

Study Start

August 1, 2007

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

October 14, 2025

Record last verified: 2025-10

Locations

US(1)