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NCT00073060 · ClinicalTrials.gov registry record
Citrate Effects and Bone Density in Long-Term Apheresis Donors
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 273
- Enrollment target
NCT00073060 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 273 participants.
The verdict
NCT00073060 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 273 participants
- Enrollment target
Study Summary
This study will examine the effects of repeated apheresis procedures on bone density and calcium balance. Apheresis is a procedure for collecting large numbers of a specific blood component, such as white cells (leukapheresis) or platelets (plateletpheresis). For the procedure, whole blood is collected through a needle in an arm vein and is directed through a machine that separates it into its components by spinning. The desired cells are removed and the rest of the blood is returned to the donor, either through the same needle or through a needle in the other arm. A blood thinning medicine called citrate is added to the cell-separating machine. Citrate reduces the ionized calcium levels in the blood, which prevents the blood from clotting. When the blood is returned to the donor, the donor also receives the citrate. This lowers the donor's ionized calcium levels which may irritate nerve and muscle cells, causing tingling around the mouth, hands, and feet during the procedure. The reduced ionized calcium levels result in increased parathyroid hormone levels in the donor, can effect bone calcium stores. In addition, some of the citrate that is returned to the donor is excreted in the urine along with calcium, which causes further loss of calcium from the body. It is not known if the calcium loss during apheresis in people who undergo this procedure repeatedly has any long-term effects on body calcium balance and bone calcium stores. This study will measure bone density and calcium balance in long-term platelet and white cell donors and compare the findings with those of whole blood donors, who do not receive citrate. Healthy people between 18 and 80 years of age who weigh between 110 and 300 pounds, do not have a metal prosthesis, and are not pregnant may be eligible for this study. Participants undergo the following procedures: Whole blood donors * Blood sample collection 2 weeks before blood donation. * I removed undergo standard whole blood donation * Urine sam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2003-11-17 |
| Est. Completion | 2008-08-26 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00073060
The ClinicalTrials.gov registry entry for NCT00073060 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 273 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00073060 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00073060 about?
NCT00073060 is a clinical study titled "Citrate Effects and Bone Density in Long-Term Apheresis Donors". This study will examine the effects of repeated apheresis procedures on bone density and calcium balance. Apheresis is a procedure for collecting large numbers of a specific blood component, such as white cells (leukapheresis) or platelets (plateletpheresis). For the procedure, whole blood is collec...
What is the current status of trial NCT00073060?
This trial is currently completed. The enrollment target is 273 participants. The study started on 2003-11-17. Estimated completion is 2008-08-26.
Who is sponsoring clinical trial NCT00073060?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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