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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01365104
Other study ID # 1K23AG030967-01
Secondary ID 1K23AG030967-01A
Status Completed
Phase Phase 0
First received May 31, 2011
Last updated January 26, 2015
Start date March 2008
Est. completion date December 2014

Study information

Verified date January 2015
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Data Safety Monitoring Board/NIA
Study type Interventional

Clinical Trial Summary

The purpose of this study is determine if the iron chelator, desferrioxamine can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date December 2014
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- healthy adults between the ages of 18-80 years.

Exclusion Criteria:

- subjects taking vasoactive medications,

- hypertension,

- pregnant women, smokers,

- COPD,

- asthma,

- diabetes mellitus,

- intracranial or carotid stenosis,

- hepatic disease,

- renal disease,

- bone marrow suppression,

- cardiac disease,

- heart failure,

- iron deficiency,

- history of cancer,

- history of head trauma,

- subarachnoid hemorrhage,

- central nervous system vasculitis,

- multiple sclerosis,

- migraines,

- seizures,

- sickle cell disease or trait,

- cardiac arrhythmia,

- unable to give informed consent, or

- poor transcranial Doppler insonation windows.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
desferrioxamine
intravenous infusion at 10mg/kg/hr for a total of 6 hours at final infused doses of 60mg/kg.

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Define change from baseline cerebral blood flow after receiving DFO infusion. Cerebral blood flow is measured with transcranial Doppler ultrasound at baseline and then study drug is initiated. Blood flow is measured again after 3 hours of infusion, 6 hours of infusion, then once more 3 hours after the infusion is complete. baseline, 3hr, 6hr, 9hr No
Primary Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics. Blood samples are taken at each time point and will be correlated with ultrasound blood flow measures taken at baseline, 3hrs of infusion, 6hrs of infusion, and 3 hours after infusion is complete. baseline, 3hr, 6hr, 9hr No
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