Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease
NCT ID: NCT05170412
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2022-05-26
2026-12-31
Brief Summary
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Sickle Cell Disease (SCD) causes blood cells form a crescent shape. It is caused by a genetic mutation in the hemoglobin gene. People with SCD are at increased risk for illnesses like stroke, chronic pain, and heart problems, as well as decreased overall health and well-being. Researchers want to learn more about how nutrition and diet can help relieve or reduce the symptoms of SCD.
Objective:
To understand how diet, dietary patterns and behaviors, nutrition, and other related factors in adults with SCD affect their overall health.
Eligibility:
Adults aged 18 and older with SCD.
Design:
Participants will be screened with a review of their medical records. They will take a pregnancy test if needed.
Participants will have a physical exam and medical history. Their height, weight, and waist and hip circumference will be measured. They can complete this exam (1) via telehealth along with a visit to an outpatient laboratory center or (2) by going to the NIH Clinical Center.
Participants will complete 2 interviews about their diet. They will talk about the foods they ate in the past 24 hours. They will also complete 1 interview about diet-related behaviors such as food shopping and cooking. They can complete the interviews in person, by phone, or by telehealth visit.
Participants will complete surveys about their demographics (such as age and gender), SCD pain, mood, stress, diet, and nutrition. It may take about 1 hour to complete all of the surveys.
Participants will give blood and urine samples. They will need to fast for at least 8 hours overnight before giving blood samples.
Participation will last for about 2 weeks.
Detailed Description
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This study seeks to determine dietary intake and behaviors of adults with Sickle Cell Disease through the use of a cross-sectional design using mixed methods. The premise for the study is based on the potential role of nutritional status in sickle cell disease outcomes in physical health and psychosocial health. The study will recruit outpatient adults with the diagnosis of Sickle Cell Disease, and will include patients with multiple clinical phenotypes and genotypes.
Objectives:
Primary Objective: The primary objective is to assess the dietary intake and behaviors of outpatient adults with SCD within the context of social determinants of health.
Secondary Objective 1: Identify associations between dietary intake and behaviors with clinical severity outcomes.
Secondary objective 2: Identify associations between dietary intake and behaviors with psychosocial variables.
Secondary objective 3: Identify associations between food access and dietary intake and behaviors.
Endpoints:
Primary Endpoint: Measure dietary intake and behaviors using 24-hour dietary recall data, participant survey responses and diet-related laboratory results
Secondary Endpoints: Identify associations between dietary intake and behaviors with: 1) social determinants of health (related to socioeconomic status, birthplace, neighborhood disadvantage, food environment); 2) clinical variables SCD of genotype, clinical phenotype (SCD related diagnoses and complications), clinical severity (chronic pain severity and frequency), medication use and
history of treatments, and SCD related laboratory studies; 3) psychosocial variables of mood, self-esteem, perceived stress, social support, self-mastery, self-compassion, racial identity, and stigmatization as measured by self-reported responses.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Patients
outpatient adults with the diagnosis of Sickle Cell Disease
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. State their willingness to complete all study procedures for the duration of the study
2. 18 years of age or older at the time of screening
3. Have a documented clinical diagnosis (upon review of medical records) of SCD or presence of a SCD hemoglobinopathy genotype HbSS, HgSC, HbSB 0 or HBSB+
Exclusion Criteria
1. Less than 18 years of age
2. Unable to speak, read, write, and/or understand English
3. Presence of a condition or illness that will hamper the individual from giving informed consent (e.g. cognitive impairment)
4. SCD trait genotype
5. Currently undergoing inpatient treatment in any hospital for SCD at the time of screening
6. Pregnancy at the time of screening
18 Years
120 Years
ALL
No
Sponsors
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National Human Genome Research Institute (NHGRI)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Institutes of Health Clinical Center (CC)
NIH
Responsible Party
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Principal Investigators
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Nicole M Farmer, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institutes of Health Clinical Center (CC)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Role: primary
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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000518-CC
Identifier Type: -
Identifier Source: secondary_id
10000518
Identifier Type: -
Identifier Source: org_study_id