NCT00748228

Brief Summary

One goal of this study is to determine whether people with different amounts of dopamine-beta-hydroxylase (DBH) have different responses to events that affect blood pressure and heart rate. We will also study whether increasing dietary salt improves symptoms during upright posture. Finally, we will examine whether the dietary sodium level influences serum DBH activity and whether DBH level influences the response to sodium. DBH levels and the function of the sympathetic or involuntary nervous system will be assessed in normal volunteers and in patients with postural tachycardia syndrome (POTS).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

7.7 years

First QC Date

September 5, 2008

Last Update Submit

June 11, 2015

Conditions

Postural Tachycardia Syndrome

Outcome Measures

Primary Outcomes (2)

  • plasma dopamine-beta-hydroxylase

    at enrollment and after tests

  • plasma dopamine

    after tests

Study Arms (3)

A

EXPERIMENTAL

10 mEq/day dietary sodium

Dietary Supplement: dietary sodium

B

EXPERIMENTAL

150 mEq/day dietary sodium

Dietary Supplement: dietary sodium

C

EXPERIMENTAL

300 mEq/day dietary sodium

Dietary Supplement: dietary sodium

Interventions

dietary sodiumDIETARY_SUPPLEMENT

10 mEq/day

A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Upright plasma norepinephrine \> 600 pg/ml, or
  • An increase in heart rate of \> 30 beats per minute upon standing, and
  • Withdrawal of all medications for at least 3 days, and
  • No associated medical illness, and
  • Age 18 - 60 years old.

You may not qualify if:

  • Older than 60 years of age
  • Routinely taking medications affecting the autonomic nervous system
  • Any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic) other than POTS
  • Anemia (Hct \< 30)
  • Women of childbearing age who are pregnant or nursing
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Sodium, Dietary

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Sodium CompoundsInorganic Chemicals

Study Officials

  • Emily M Garland, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 8, 2008

Study Start

November 1, 2004

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations

US(1)