Recruiting

Sickle Cell Disease

Sponsor:

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

Code:

NCT00542230

Conditions

Sickle Cell Trait

Sickle Cell Disease

Sickle Cell Anemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT00542230

Start date

Nov 7, 2007

Status verified date

May 8, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:
  • 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

EXCLUSION CRITERIA:

  • 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.

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Volunteers

Healthy Volunteers

Sickle Cell Trait

Patient with sickle cell trait or disease

Primary outcome measure

  • 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. [ Time Frame: daily ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

More Information

Sponsor

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

Last update posted

Aug 24, 2026

Last verified

May 8, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on 2026-08-24.