Mechanisms Accounting for Unexplained Anemia in the Elderly

NCT01572506 | Completed Phase 1 FDA Drug

• 2 other identifiers: 99991210912-AG-N109
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anemia

Keywords

Anemia; Elderly; Mechanisms; Red Cell Survival

Outcome Measures

Primary Outcomes (1)

• Measurement of red blood cell survival

  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

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Age 70 and older with unexplained anemia

Drug: Biotin RBC survival

Group 2

ACTIVE COMPARATOR

Age 70 and older with iron deficient anemia

Drug: Biotin RBC survival

Group 3

ACTIVE COMPARATOR

Age 70 and older without anemia

Drug: Biotin RBC survival

Group 4

ACTIVE COMPARATOR

Age 18 - 50 without anemia

Drug: Biotin RBC survival

Interventions

Biotin RBC survival DRUG

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 transplant
• Use of exogenous erythropoietin during the past 3 months
• Any major surgery requiring general anesthesia within the past 3 months
• Treatment with chemotherapy or radiotherapy in the past 12 months
• Current diagnosis of active cancer, other than non-melanoma skin cancer and, stable prostate cancer
• History of blood disorders including thalassemia, sickle cell disease or myelodysplasia
• Current severe (NYHA Class III - IV) congestive heart failure or advanced chronic obstructive pulmonary disease
• Positive serum monoclonal protein and immunofixation
• Women who are pregnant or women planning to get pregnant during the duration of the study or those with a positive pregnancy test during screening

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• Ershler WB, Sheng S, McKelvey J, Artz AS, Denduluri N, Tecson J, Taub DD, Brant LJ, Ferrucci L, Longo DL. Serum erythropoietin and aging: a longitudinal analysis. J Am Geriatr Soc. 2005 Aug;53(8):1360-5. doi: 10.1111/j.1532-5415.2005.53416.x.

  PMID: 16078962 BACKGROUND

• Guralnik JM, Eisenstaedt RS, Ferrucci L, Klein HG, Woodman RC. Prevalence of anemia in persons 65 years and older in the United States: evidence for a high rate of unexplained anemia. Blood. 2004 Oct 15;104(8):2263-8. doi: 10.1182/blood-2004-05-1812. Epub 2004 Jul 6.

  PMID: 15238427 BACKGROUND

• Artz AS, Fergusson D, Drinka PJ, Gerald M, Gravenstein S, Lechich A, Silverstone F, Finnigan S, Janowski MC, McCamish MA, Ershler WB. Prevalence of anemia in skilled-nursing home residents. Arch Gerontol Geriatr. 2004 Nov-Dec;39(3):201-6. doi: 10.1016/j.archger.2004.03.006.

  PMID: 15381339 BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Josephine M Egan, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 6, 2012
• Study Start: March 29, 2012
• Primary Completion: July 30, 2015
• Study Completion: July 30, 2015
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

US (1)