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NCT01572506 · ClinicalTrials.gov registry record · Phase 1

Mechanisms Accounting for Unexplained Anemia in the Elderly

A Phase 1 study, sponsored by National Institute on Aging (NIA).

Completed
Registry status
Phase 1
Development phase
58
Enrollment target

NCT01572506: Completed Phase 1 study, sponsored by National Institute on Aging (NIA).

NCT01572506 is a Phase 1 study that has completed, run by National Institute on Aging (NIA). The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01572506, a Phase 1 study, has completed, sponsored by National Institute on Aging (NIA).

COMPLETED
Registry status
Phase 1
Development phase
58 participants
Enrollment target

Study 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.

Primary Outcome

Directly measure red blood cell survival and to correlate this with aspects of red blood cell physiology that may increase susceptibilty to the hemolytic process

Interventions

  • DRUG Biotin RBC survival

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2012-03-29
Est. Completion 2015-07-30
Phase Phase 1
National Institute on Aging (NIA)

131 total trials

What the finished NCT01572506 record still lists

NCT01572506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which Biotin RBC survival is the first listed.

NCT01572506 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01572506 about?

NCT01572506 is a clinical study titled "Mechanisms Accounting for Unexplained Anemia in the Elderly". 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 t...

What is the current status of trial NCT01572506?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2012-03-29. Estimated completion is 2015-07-30.

What interventions are being tested in trial NCT01572506?

The interventions under investigation include: Biotin RBC survival (DRUG).

Who is sponsoring clinical trial NCT01572506?

This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01572506's enrollment target sits among peer trials

58 895th of 2000 higher than 1,100 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01572506, the US trial registry maintained by the National Library of Medicine. NCT01572506 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.