Status:
COMPLETED
Nitrite Infusion in Healthy Volunteers
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Healthy
Eligibility:
All Genders
21-60 years
Phase:
PHASE1
Brief Summary
This study will determine the dose of sodium nitrite that can safely be used to prevent constriction, or tightening, of the arteries. Narrowed arteries in the brain can cause stroke. Animal studies sh...
Detailed Description
Nitric oxide (NO) is beneficial in treatment of many animal models of diseases like heart and brain ischemia, reperfusion injury, and delayed cerebral vasospasm after subarachnoid hemorrhage. It also ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects must be 21-60 years of age.
- Subjects must be in good health.
- Subjects must provide informed, written consent for participation in this study.
- Female subjects of childbearing age must have a negative pregnancy test and agree to participate in assessment of menstrual cycle duration before, during, and after infusion.
- Subjects must be willing to temporarily stop any medications (except oral contraception), vitamin supplements, herbal medicines.
- Subjects will have hemoglobin levels above 11.1 g/dL.
- EXCLUSION CRITERIA:
- Subjects with a history or evidence of present or past hypertension (blood pressure greater than 140/90 mmHg), hypercholesterolemia (LDL cholesterol greater than 130 mg/dL), or diabetes mellitus (fasting blood glucose greater than 126 mg/dL).
- Subjects who have a history of smoking within two years.
- Subjects who have a history of cardiovascular disease, peripheral vascular disease, coagulopathy, or any other disease predisposing to vasculitis or Raynaud's phenomenon.
- Subjects with red blood cell G6PD deficiency (levels below the lower limits of normal).
- Subjects with a history of reaction to a medication or other substance characterized by dyspnea and cyanosis.
- Subjects with a baseline methemoglobin level greater than 1%.
- Pregnant women, since nitrite may cross the placenta; nitrite effect on fetus is unknown and mother's methemoglobinemia may be dangerous to the fetus.
- Breast-feeding females, since nitrite crosses into breast milk and could cause methemoglobinemia in the infant.
- Subjects with a blood pressure of less than 100/70 mmHg on the study day.
- Subjects treated with nitrates (e.g. nitroglycerin).
Exclusion
Key Trial Info
Start Date :
February 4 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00103025
Start Date
February 4 2005
End Date
May 10 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892