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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00748228
Other study ID # 040769
Secondary ID HL071784
Status Terminated
Phase N/A
First received September 5, 2008
Last updated June 11, 2015
Start date November 2004
Est. completion date July 2012

Study information

Verified date June 2015
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 22
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
dietary sodium
10 mEq/day
dietary sodium
300 mEq/day
dietary sodium
150 mEq/day dietary sodium

Locations

Country Name City State
United States Vanderbilt University Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary plasma dopamine-beta-hydroxylase at enrollment and after tests No
Primary plasma dopamine after tests No
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