Nitric Oxide and Sickle Cell Pain

NCT01393847 | Terminated

• 2 other identifiers: 11018911-NR-0189
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sickle Cell Disease; Pain

Keywords

Sickle Cell; Pain; Genetics; Sickle Cell Disease; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects with sickle cell disease will be eligible for enrollment in this study if they meet all of the following criteria:
• 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
• All volunteer matched control study participants will be eligible for enrollment on this study if they meet all the following criteria:
• 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

You may not qualify if:

• 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:
• Chronic inflammatory disease (i.e. rheumatoid arthritis, systemic lupus erythematosus, cirrhosis)
• Diabetes mellitus
• Uncontrolled hypertension
• Known malignancies

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 18988877 BACKGROUND

• Hagar 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.

  PMID: 18341629 BACKGROUND

• McClish 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.

  PMID: 19631468 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alan N Schechter, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 13, 2011
• Study Start: June 17, 2011
• Study Completion: December 5, 2013
• Last Updated: July 2, 2017

Record last verified: 2013-12-05

Locations

US (1)