Blood Sampling for Research Related to Sickle Cell Disease

NCT00542230 | Recruiting

• 2 other identifiers: 08000408-DK-0004
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study will collect representative blood samples from healthy children and adults and from children and adults who have unique red blood cell features that are related to sickle cell disease. Sickle cell disease is a blood disease that limits the ability of red blood cells to carry oxygen throughout the body. The purpose of the study is to collect a variety of blood samples that may then be used to investigate advances and potential new drug treatments for sickle cell disease. Volunteers must be at least 18 years of old. Samples will be taken both from healthy volunteers and from volunteers who have unique red blood cell features that are related to sickle cell disease. Candidates will be screened with a medical history. During the study, participants will undergo a one- to two-hour outpatient procedure at the National Institutes of Health Clinical Center. Once researchers have explained the study and obtained the participant s consent, participants will donate 8 cc (approximately 2 teaspoons) of blood. Because repeat testing helps researchers validate study findings, participants who have the unique red blood cell features mentioned above may also be asked if they are willing to return and donate another 2 cc to 8 cc of blood for additional studies. The amount of blood drawn will not exceed 50 ml with any eight-week period for adults or 7 cc within any six-week period for children.

Conditions

Sickle Cell Trait; Sickle Cell Disease; Sickle Cell Anemia

Keywords

Erythrocytes; Drug Screen; Sickle Cell Trait; Sickle Hemoglobin; Sickle Cell Disease; Natural History

Outcome Measures

Primary Outcomes (1)

• To screen large compound libraries for anti-sickling activity, particularly compounds that are already FDA-approved drugs, with the goal of discovering a drug for treating sickle cell disease.

  To identify by high sensitivity in vitro screening methods additional compounds that inhibit sickling

  daily

Study Arms (2)

Healthy Volunteers

Healthy Volunteers

Sickle Cell Trait

Patient with sickle cell trait or disease

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary clinical

You may qualify if:

• Patients with sickle cell trait
• Patients with known hemoglobinopathies involving one or two genes for sickle hemoglobin
• Healthy volunteers for control experiments
• Age range: adults greater than or equal to 18 years of age

You may not qualify if:

• Subjects who are unable to comprehend the investigational nature of the laboratory research are ineligible to enroll in this protocol.
• As a safety precaution in handling the blood samples, patients with HIV, Hepatitis B or Hepatitis C will be excluded from the study. HIV, Hepatitis B or Hepatitits C testing will not be done under this study. Participants must be co-enrolled under another NIH protocol where the screening evaluation has been performed.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Sickle Cell Trait; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• William A Eaton, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William A Eaton, M.D.

CONTACT

(301) 496-6030; eaton@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: November 7, 2007
• Last Updated: March 9, 2026

Record last verified: 2025-10-27

Locations

US (1)