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NCT00048477 · ClinicalTrials.gov registry record · Phase 2
Effects of Nitrite on Blood Vessel Dilation in Normal Volunteers
A Phase 2 study of Healthy and Nitric Oxide, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT00048477 is a Phase 2 study of Healthy and Nitric Oxide that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 42 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00048477, a Phase 2 study of Healthy and Nitric Oxide, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
Nitric oxide gas is important in regulating blood vessel dilation, and consequently, blood flow. This gas is continuously produced by endothelial cells, which line the blood vessels. This study will examine whether nitrite, a molecule that normally circulates in the blood stream, can also dilate blood vessels. The results of this study may be valuable in developing treatments for people with conditions associated with impaired endothelial production of nitric oxide, including high blood pressure, high blood cholesterol, diabetes, estrogen deficiency, and others. Healthy, non-smoking normal volunteers 21 years of age or older may be eligible for this study. People who lack the enzyme G6PD or cytochrome B5 in their red blood cells may not participate. Absence of these enzymes can lead to episodes of sudden shortness of breath and cyanosis (blueness of the skin due to lack of sufficient oxygen). Participants will undergo the procedures described in study Parts A and B, as follows: * Part A - After numbing the skin, small tubes are placed in the artery and vein at the inside of the elbow of the dominant arm (right- or left-handed) and a small tube is placed in a vein of the other arm. The tubes are used for infusing saline (salt water) and for drawing blood samples. A pressure cuff is placed around the upper part of the dominant arm, and a rubber band device called a strain gauge is also placed around the arm to measure blood flow. When the cuff is inflated, blood flows into the arm, stretching the strain gauge at a rate proportional to the flow. Grip-strength of the dominant arm is measured with a dynamometer to determine maximum grip-strength. Then, several measurements of blood flow, nitrite, hemoglobin, and handgrip are made before and after administration of L-NMMA, a drug that blocks endothelial production of nitric oxide. * Part B - Part A testing is repeated, except that sodium nitrite dissolved in a saline solution is infused into the artery of the forearm fo
Conditions Studied
Interventions
- DRUG L-NMMA and Sodium Nitrite
Study Locations (1)
Maryland
- National Heart, Lung and Blood Institute (NHLBI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2002-10 |
| Est. Completion | 2003-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00048477
The ClinicalTrials.gov registry entry for NCT00048477 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which L-NMMA and Sodium Nitrite is the first listed.
NCT00048477 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00048477 about?
NCT00048477 is a clinical study titled "Effects of Nitrite on Blood Vessel Dilation in Normal Volunteers". Nitric oxide gas is important in regulating blood vessel dilation, and consequently, blood flow. This gas is continuously produced by endothelial cells, which line the blood vessels. This study will examine whether nitrite, a molecule that normally circulates in the blood stream, can also dilate blo...
What is the current status of trial NCT00048477?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2002-10. Estimated completion is 2003-11.
What conditions does trial NCT00048477 study?
This clinical trial studies the following conditions: Healthy, Nitric Oxide, Endothelium-Derived Relaxing Factor.
What interventions are being tested in trial NCT00048477?
The interventions under investigation include: L-NMMA and Sodium Nitrite (DRUG).
Who is sponsoring clinical trial NCT00048477?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00048477 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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