NCT00580996

Brief Summary

We are studying the effects of oral water ingestion in patients with orthostatic hypotension. In this study, we are testing the null hypothesis that the blood pressure increase with oral water ingestion will not be diminished if a full prior water dose is given a few hours earlier.

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 Jul 2006

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 Progress85%
Jul 2006Dec 2029

Study Start

First participant enrolled

July 1, 2006

Completed
1.5 years 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 10, 2025

Status Verified

October 1, 2025

Enrollment Period

23.4 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

    2nd water intervention

Secondary Outcomes (1)

  • heart rate

    2nd intervention

Study Arms (2)

1

EXPERIMENTAL

16 oz water in AM

Other: water high dose

2

ACTIVE COMPARATOR

water 1 oz in AM

Other: water tiny dose

Interventions

water high doseOTHER

water 16 oz PO x 1

1
water tiny doseOTHER

water 1 oz PO x 1

2

Eligibility Criteria

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

You may qualify if:

  • orthostatic hypotension (fall in BP\>20/10 mmHg)
  • pressor response to water in other studies
  • Age 18-80 years

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

Interventions

Water

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Satish R Raj, MD MSCI

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
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

July 1, 2006

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

October 10, 2025

Record last verified: 2025-10

Locations

US(1)