Sickle Cell TraitNCT00542230
Blood Sampling for Research Related to Sickle Cell Disease
An observational study of Sickle Cell Trait and Sickle Cell Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Trait, Sickle Cell Disease, Sickle Cell Anemia
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2007to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary clinical
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: High Sensitivity Screening of Compound Libraries to Discover a Drug for the Treatment of Sickle Cell Disease
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.
Read more
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.
Read the detailed description
The critical event leading to serious morbidity in sickle cell disease is polymerization of the abnormal hemoglobin to form fibers that stiffen and distort red blood cells and consequently, cause vaso-occlusion in the small vessels of the tissues. Currently, hydroxyurea is the only approved drug for treating sickle cell disease, but is only partially effective. This protocol seeks to identify by high sensitivity in vitro screening methods additional compounds that inhibit sickling. Subjects with sickle cell trait or disease and normal volunteers will be asked to donate blood samples for studies to verify their hemoglobinopathies and then periodically donate small volume samples of fresh blood for use in ongoing high throughput screening tests to identify potentially clinically useful anti-sickling drugs.
- Conditions
- Sickle Cell Trait, Sickle Cell Disease, Sickle Cell Anemia
- Keywords
- Erythrocytes, Drug Screen, Sickle Cell Trait, Sickle Hemoglobin, Sickle Cell Disease, Natural History
- Medical subject headings
- Sickle Cell Trait, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy Volunteers | |
| Sickle Cell Trait | Patient with sickle cell trait or disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study start7 Nov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell TraitStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William A Eaton, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542230
- Sponsor's protocol ID
- 080004
- Other IDs
- 08-DK-0004
- Status last verified
- 25 Sep 2026
- First submitted
- 10 Oct 2007
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Sensitivity Screening of Compound Libraries to Discover a Drug for the Treatment of Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT00542230
- Acronym / sponsor ID
- 080004
- Conditions
- Sickle Cell Trait, Sickle Cell Disease, Sickle Cell Anemia
- Keywords
- Erythrocytes, Drug Screen, Sickle Cell Trait, Sickle Hemoglobin, Sickle Cell Disease, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 7 Nov 2007 (actual)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The critical event leading to serious morbidity in sickle cell disease is polymerization of the abnormal hemoglobin to form fibers that stiffen and distort red blood cells and consequently, cause vaso-occlusion in the small vessels of the tissues. Currently, hydroxyurea is the only approved drug for treating sickle cell disease, but is only partially effective. This protocol seeks to identify by high sensitivity in vitro screening methods additional compounds that inhibit sickling. Subjects with sickle cell trait or disease and normal volunteers will be asked to donate blood samples for studies to verify their hemoglobinopathies and then periodically donate small volume samples of fresh blood for use in ongoing high throughput screening tests to identify potentially clinically useful anti-sickling drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy Volunteers |
| Sickle Cell Trait | – | –Patient with sickle cell trait or disease |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary clinical
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
To identify by high sensitivity in vitro screening methods additional compounds that inhibit sickling
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for Sickle Cell Trait
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William A Eaton, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Trait and Sickle Cell Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William A Eaton, M.D. ((301) 496-6030, eaton@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.