Mechanisms Accounting for Unexplained Anemia in the Elderly (NCT01572506) | Clinical Trial Compass
CompletedPhase 1
Mechanisms Accounting for Unexplained Anemia in the Elderly
United States58 participantsStarted 2012-03-29
Plain-language summary
Background:
\- Anemia occurs commonly and is associated with poor outcomes in the elderly. In about a third of anemia cases in older people (over age 65), the cause of anemia is unexplained. Anemia in older adults may be caused by the bone marrow's inability to produce red blood cells fast enough to replace older red blood cells that have died. Researchers want to look at unexplained anemia by studying the life span of red blood cells in younger adults and older adults. To do so, a vitamin called Biotin will be used as a marker on the red blood cells.
Objectives:
\- To investigate possible causes of unexplained anemia in older people.
Eligibility:
* Individuals in the following groups:
* Men and women between 18 and 50 years of age who do not have anemia
* Men and women at least 70 years of age who do not have anemia.
* Men and women at least 70 years of age who have iron-deficiency anemia.
* Men and women at least 70 years of age who have anemia with no known cause.
Design:
* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
* Participants will have an overnight stay for the first study visit. They will provide a blood sample to which Biotin will be added. The blood sample with Biotin will then be returned to the participant. Twenty-four hours later, another blood sample will be collected.
* Participants will have up to 14 additional study visits. At each visit, blood samples will be collected to measure the amount of Biotin remaining in the blood.
* Participants may also provide a separate blood sample for genetic testing. These tests may provide more information about genetic causes of unexplained anemia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Ambulatory, community dweller
* Age greater than or equal to 70 years or older or between the ages of 18 and 50 years.
* Able to understand English
* Able to complete study questionnaires as determined by the investigator
* Evidence for recent (within 1 year) clinical evaluation for blood loss directed by primary care physician or consultant in subjects referred with microcytic anemia or with referring laboratories indicative of iron deficiency. Furthermore, subjects found to have microcytic anemia will be eligible but will be referred to their primary doctor for evaluation of blood loss.
* Provide informed consent
EXCLUSION CRITERIA:
* Hemoglobin (Hb) less than 9 g/dL during screening
* History of red blood cell transfusion withinthe 3 month period prior to accrual to this study, or evidence for active bleeding as ascertained by medical history (e.g., persistent melena, hematuria or dysfunctional uterine bleeding).
* Patients for whom oral iron supplementation has been prescribed within the past two months. (Patients on a stable dose of oral iron for more than two months may be eligible).
* ALT or AST more than 3 times upper normal limitation of the time of screening
* B12 or folate deficiencies during screening period
* Estimated GFR less than 30 ml/min/1.73m(2)during screening period (by the 4-variable Modification of Diet in Renal Disease \[MDRD\] equation).
* Receiving hemodialysis or peritoneal dialysis for renal failure, or history of kidney t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.