Sickle Cell DiseaseNCT01393847
Nitric Oxide and Sickle Cell Pain
An observational study of Sickle Cell Disease and Pain, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial summary
Background: Sickle cell disease often causes crises, with episodes of pain. Many people with sickle cell disease also have pain between crises. Inflammation is an important part of sickle cell pain. It may be related to levels of nitric oxide. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Pain
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2011to 5 Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects with sickle cell disease will be eligible for enrollment in this study if they meet all of the following criteria:
- 18 years of age or older
- Diagnosis of sickle cell disease (electrophoretic or HPLC documentation of hemoglobin S only phenotype is required)
- No vaso-occlusive crisis during the previous two weeks
- Medically stable
- Can speak and understand English to complete assessments and scales
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- All volunteer matched control study participants will be eligible for enrollment on this study if they meet all the following criteria:
- 18 years of age or older
- Non-sickle cell trait or disease
- Medically healthy based upon the history and physical exam and screening blood analyses
- No chronic pain condition.
- Can speak and understand English to complete assessments and scales
- Ethnicity, age (within 5 years), and sex matched to that of sickle cell subjects already enrolled on study
Who cannot join
- Study participants will be excluded from the study if he/she has one or more of the following:
- Inability to provide his/her own informed consent.
- Drug or alcohol dependence/abuse within the past 5 years
- Cigarette smoking or the use of any tobacco products within two years
- Use of tranquilizers, steroids, non-steroidal anti-inflammatory agents three or more times per week.
- Clinically significant medical condition that will confound the analysis of factors associated with sickle cell pain, such as:
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- Chronic inflammatory disease (i.e. rheumatoid arthritis, systemic lupus erythematosus, cirrhosis)
- Diabetes mellitus
- Uncontrolled hypertension
- Known malignancies
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Biochemical and Genetic Mechanisms for Etiology of Sickle Cell Pain
Background:
- Sickle cell disease often causes crises, with episodes of pain. Many people with sickle cell disease also have pain between crises. Inflammation is an important part of sickle cell pain. It may be related to levels of nitric oxide. Nitric oxide is a gas in the body that helps relax blood vessels and may be related to the pain from sickle cell disease. Researchers want to study the relationship between blood levels of nitric oxide and pain in people with sickle cell disease. Researchers also want to study how certain genes express themselves related to sickle cell pain.
Read more
Objectives:
- To collect blood samples and other genetic expression information to study sickle cell pain and its relation to nitric oxide levels in the blood.
Eligibility:
- People at least 18 years of age who have sickle cell disease.
- Healthy volunteers at least 18 years of age.
Design:
- This study requires a screening visit and four study visits scheduled 1 week apart. Each visit will last about 1 hour.
- Participants will be screened with a medical history and physical exam. They will complete questionnaires about pain levels (if any). They will also provide blood samples for genetic and other testing.
- Participants will have a breath test to see how much nitric oxide they exhale. They will also have a test of their ability to detect small changes in temperature and touch.
- Participants will keep a diary to record daily pain levels and pain medicines taken. They will write down what they eat to track foods that contain nitrates (such as meats like ham and bacon and vegetables like beets and spinach).
- At each of the four study visit, participants will bring the pain diary, provide blood samples, and have breath nitric oxide tests.
Read the detailed description
Sickle cell disease is a systemic disorder whose proximate cause is a mutation in the beta-globin chain of hemoglobin. Although it is characterized by differing degrees and patterns of clinical manifestations, its major features include severe episodes of pain. The sickle cell pain crisis is one of the most typical characteristics of this disease and pain associated with crisis is reported to be more intense than other types of clinical pain by those with sickle cell disease and displays both nociceptive and neuropathic qualities. Pain in sickle cell disease is more widely experienced and poorly managed than previously considered. In one community sample, more than 50 percent of the patients reported experiencing pain on more than half the days of the study period. Painful crisis consist of pain experienced in different areas of the body, typically in the extremities, back, abdomen and chest and some studies suggest that patients experience prodromal or pre-crisis phases of their pain, some of which last up to 24 hours before developing the typical features of a pain crisis. The nature of pain experience in patients with sickle cell disease is not well documented nor are the mechanisms of sickle cell pain well understood.
Objectives: The first objective of the study is to characterize genetic expression data of sickle cell disease and matched controls at weekly time points over a 4 week period. The second objective is to measure levels of exhaled Nitric Oxide (eNO) and other biomarkers in sickle cell patients and in matched controls over the same time points. The third objective is to evaluate experimental pain perception in both groups.
Population: By stratifying patients by pain level, this study will recruit sickle cell patients with a range of symptom severity (N=45) and sex-, race-, ethnicity and age-matched controls (N=45) without sickle cell trait from the NIH Patient Recruitment and Referral Service.
Design: This is a prospective, exploratory study of steady state and acute pain phase in sickle cell patients. Participants will undergo evaluations (eNO and blood collection) during weekly clinic visits and keep a pain diary for 4 weeks after the first visit. All participants will also undergo one session of quantitative sensory testing.
Importance: The purpose of this study is to improve the understanding of the biochemical and molecular genetic mechanisms associated with sickle cell pain by characterizing the transcriptome of sickle cell disease during steady state and pain phases. It is hypothesized that analysis of the transcriptome will result in a panel of biomarkers that correlate with the severity level of pain and perhaps signal the onset of a painful episode. The successful elucidation of these relationships may identify novel targets for intervention leading to attenuation of sickle cell pain, improved treatment and less impact on quality of life and functional status.
- Conditions
- Sickle Cell Disease, Pain
- Keywords
- Sickle Cell, Pain, Genetics, Sickle Cell Disease, Healthy Volunteer, HV
- Medical subject headings
- Anemia, Sickle Cell, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in whole blood gene expression in the peripheral blood of sickle cell subjects and matched controls during pain and pain-free states.
Secondary outcomes (1)
Quantification of pain sensory perception, eNO, and laboratory correlates in sickle cell subjects and in matched controls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study start17 Jun 2011
- Study completion5 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Alan N Schechter, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393847
- Sponsor's protocol ID
- 110189
- Other IDs
- 11-NR-0189
- Status last verified
- 5 Dec 2013
- First submitted
- 12 Jul 2011
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Schechter AN. Hemoglobin research and the origins of molecular medicine. Blood. 2008 Nov 15;112(10):3927-38. doi: 10.1182/blood-2008-04-078188.
PubMed 18988877Hagar W, Vichinsky E. Advances in clinical research in sickle cell disease. Br J Haematol. 2008 May;141(3):346-56. doi: 10.1111/j.1365-2141.2008.07097.x. Epub 2008 Mar 12.
PubMed 18341629McClish DK, Smith WR, Dahman BA, Levenson JL, Roberts JD, Penberthy LT, Aisiku IP, Roseff SD, Bovbjerg VE. Pain site frequency and location in sickle cell disease: the PiSCES project. Pain. 2009 Sep;145(1-2):246-51. doi: 10.1016/j.pain.2009.06.029. Epub 2009 Jul 23.
PubMed 19631468
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical and Genetic Mechanisms for Etiology of Sickle Cell Pain
- ClinicalTrials.gov ID
- NCT01393847
- Acronym / sponsor ID
- 110189
- Conditions
- Sickle Cell Disease, Pain
- Keywords
- Sickle Cell, Pain, Genetics, Sickle Cell Disease, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- 17 Jun 2011
- Study completion
- 5 Dec 2013
- First posted
- 13 Jul 2011 (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.
Background:
- Sickle cell disease often causes crises, with episodes of pain. Many people with sickle cell disease also have pain between crises. Inflammation is an important part of sickle cell pain. It may be related to levels of nitric oxide. Nitric oxide is a gas in the body that helps relax blood vessels and may be related to the pain from sickle cell disease. Researchers want to study the relationship between blood levels of nitric oxide and pain in people with sickle cell disease. Researchers also want to study how certain genes express themselves related to sickle cell pain.
Objectives:
- To collect blood samples and other genetic expression information to study sickle cell pain and its relation to nitric oxide levels in the blood.
Eligibility:
- People at least 18 years of age who have sickle cell disease.
- Healthy volunteers at least 18 years of age.
Design:
- This study requires a screening visit and four study visits scheduled 1 week apart. Each visit will last about 1 hour.
- Participants will be screened with a medical history and physical exam. They will complete questionnaires about pain levels (if any). They will also provide blood samples for genetic and other testing.
- Participants will have a breath test to see how much nitric oxide they exhale. They will also have a test of their ability to detect small changes in temperature and touch.
- Participants will keep a diary to record daily pain levels and pain medicines taken. They will write down what they eat to track foods that contain nitrates (such as meats like ham and bacon and vegetables like beets and spinach).
- At each of the four study visit, participants will bring the pain diary, provide blood samples, and have breath nitric oxide tests.
Detailed description
Sickle cell disease is a systemic disorder whose proximate cause is a mutation in the beta-globin chain of hemoglobin. Although it is characterized by differing degrees and patterns of clinical manifestations, its major features include severe episodes of pain. The sickle cell pain crisis is one of the most typical characteristics of this disease and pain associated with crisis is reported to be more intense than other types of clinical pain by those with sickle cell disease and displays both nociceptive and neuropathic qualities. Pain in sickle cell disease is more widely experienced and poorly managed than previously considered. In one community sample, more than 50 percent of the patients reported experiencing pain on more than half the days of the study period. Painful crisis consist of pain experienced in different areas of the body, typically in the extremities, back, abdomen and chest and some studies suggest that patients experience prodromal or pre-crisis phases of their pain, some of which last up to 24 hours before developing the typical features of a pain crisis. The nature of pain experience in patients with sickle cell disease is not well documented nor are the mechanisms of sickle cell pain well understood.
Objectives: The first objective of the study is to characterize genetic expression data of sickle cell disease and matched controls at weekly time points over a 4 week period. The second objective is to measure levels of exhaled Nitric Oxide (eNO) and other biomarkers in sickle cell patients and in matched controls over the same time points. The third objective is to evaluate experimental pain perception in both groups.
Population: By stratifying patients by pain level, this study will recruit sickle cell patients with a range of symptom severity (N=45) and sex-, race-, ethnicity and age-matched controls (N=45) without sickle cell trait from the NIH Patient Recruitment and Referral Service.
Design: This is a prospective, exploratory study of steady state and acute pain phase in sickle cell patients. Participants will undergo evaluations (eNO and blood collection) during weekly clinic visits and keep a pain diary for 4 weeks after the first visit. All participants will also undergo one session of quantitative sensory testing.
Importance: The purpose of this study is to improve the understanding of the biochemical and molecular genetic mechanisms associated with sickle cell pain by characterizing the transcriptome of sickle cell disease during steady state and pain phases. It is hypothesized that analysis of the transcriptome will result in a panel of biomarkers that correlate with the severity level of pain and perhaps signal the onset of a painful episode. The successful elucidation of these relationships may identify novel targets for intervention leading to attenuation of sickle cell pain, improved treatment and less impact on quality of life and functional status.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- All subjects with sickle cell disease will be eligible for enrollment in this study if they meet all of the following criteria:
- 18 years of age or older
- Diagnosis of sickle cell disease (electrophoretic or HPLC documentation of hemoglobin S only phenotype is required)
- No vaso-occlusive crisis during the previous two weeks
- Medically stable
Key exclusion criteria (10 listed)
- Study participants will be excluded from the study if he/she has one or more of the following:
- Inability to provide his/her own informed consent.
- Drug or alcohol dependence/abuse within the past 5 years
- Cigarette smoking or the use of any tobacco products within two years
- Use of tranquilizers, steroids, non-steroidal anti-inflammatory agents three or more times per week.
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
Difference in whole blood gene expression in the peripheral blood of sickle cell subjects and matched controls during pain and pain-free states.
1 secondary outcome
Quantification of pain sensory perception, eNO, and laboratory correlates in sickle cell subjects and in matched controls
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 18988877Schechter AN. Hemoglobin research and the origins of molecular medicine. Blood. 2008 Nov 15;112(10):3927-38. doi: 10.1182/blood-2008-04-078188.
- Background: PubMed 18341629Hagar W, Vichinsky E. Advances in clinical research in sickle cell disease. Br J Haematol. 2008 May;141(3):346-56. doi: 10.1111/j.1365-2141.2008.07097.x. Epub 2008 Mar 12.
- Background: PubMed 19631468McClish DK, Smith WR, Dahman BA, Levenson JL, Roberts JD, Penberthy LT, Aisiku IP, Roseff SD, Bovbjerg VE. Pain site frequency and location in sickle cell disease: the PiSCES project. Pain. 2009 Sep;145(1-2):246-51. doi: 10.1016/j.pain.2009.06.029. Epub 2009 Jul 23.
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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. This study is not recruiting at the moment.
Alan N Schechter, 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 Disease and Pain, run by National Institute of Nursing Research (NINR) 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 13 inclusion and 10 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: stopped early, as of the sponsor's last update on 2 Jul 2017. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in whole blood gene expression in the peripheral blood of sickle cell subjects and matched controls during pain and pain-free states.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01393847, which also lists 3 linked publications.
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 2 Jul 2017; AzTrials last refreshed its copy on 3 Nov 2026.