Sickle Cell DiseaseNCT05170412
Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease
An observational study of Sickle Cell Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2022to 31 Dec 2027
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: male and female; age: >= 18 years of age; health status: diagnosis of Sickle Cell Disease
Who may be able to join
- In order to be eligible to participate in this study, the participant must:
- State their willingness to complete all study procedures for the duration of the study
- 18 years of age or older at the time of screening
- 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+
Who cannot join
- The following criteria will exclude any individual from participating in the study:
- Less than 18 years of age
- Unable to speak, read, write, and/or understand English
- Presence of a condition or illness that will hamper the individual from giving informed consent (e.g. cognitive impairment)
- SCD trait genotype
- Currently undergoing inpatient treatment in any hospital for SCD at the time of screening
- Pregnancy at the time of screening
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
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Observational Study of Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease
Background:
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.
Read more
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.
Read the detailed description
Study Description:
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
- Sickle Cell Disease
- Keywords
- cross-sectional design, Nutritional Status, physical health, psychosocial health, clinical phenotypes, Natural History
- Medical subject headings
- 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 |
|---|---|---|
| Patients | outpatient adults with the diagnosis of Sickle Cell Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the dietary intake and behaviors of outpatient adults with SCD
assess the dietary intake and behaviors of outpatient adults with SCD
Measured: 24 months
Secondary outcomes (3)
demographic variables related to socioeconomic status, sex, age, birthplace
Identify if associations exist between dietary intake and behaviors
Measured: 24 months
SCD 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.
Identify if associations exist with dietary intake and behaviors with SCD 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.
Measured: 24 months
psychosocial variables of mood, self-esteem, perceived stress, social support, self-mastery, self-compassion, racial identity, and stigmatization as measured by self-reported responses
Identify if associations exist between dietary intake and behaviors with the psychosocial variables of mood, self-esteem, perceived stress, social support, self-mastery, self-compassion, racial identity, and stigmatization as measured by self-reported responses.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start26 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Human Genome Research Institute (NHGRI), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nicole M Farmer, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170412
- Sponsor's protocol ID
- 10000518
- Other IDs
- 000518-CC
- Status last verified
- 16 Sep 2026
- First submitted
- 24 Dec 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT05170412
- Acronym / sponsor ID
- 10000518
- Conditions
- Sickle Cell Disease
- Keywords
- cross-sectional design, Nutritional Status, physical health, psychosocial health, clinical phenotypes, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Human Genome Research Institute (NHGRI), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 26 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Dec 2021 (actual)
- 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 (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
Study Description:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –outpatient adults with the diagnosis of Sickle Cell Disease |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male and female; age: >= 18 years of age; health status: diagnosis of Sickle Cell Disease
Key inclusion criteria (4 listed)
- State their willingness to complete all study procedures for the duration of the study
- 18 years of age or older at the time of screening
- 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+
Key exclusion criteria (7 listed)
- Less than 18 years of age
- Unable to speak, read, write, and/or understand English
- Presence of a condition or illness that will hamper the individual from giving informed consent (e.g. cognitive impairment)
- SCD trait genotype
- Currently undergoing inpatient treatment in any hospital for SCD at the time of screening
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
assess the dietary intake and behaviors of outpatient adults with SCD
Time frame: 24 months
assess the dietary intake and behaviors of outpatient adults with SCD
3 secondary outcomes
demographic variables related to socioeconomic status, sex, age, birthplace
Time frame: 24 months
SCD 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.
Time frame: 24 months
psychosocial variables of mood, self-esteem, perceived stress, social support, self-mastery, self-compassion, racial identity, and stigmatization as measured by self-reported responses
Time frame: 24 months
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 18 Sep 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Sickle Cell Disease
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
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.
Nicole M Farmer, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
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, run by National Institutes of Health Clinical Center (CC) 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 7 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 18 Sep 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 Stephanie L Wildridge, R.N. ((240) 927-2603, wildridgesl@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the dietary intake and behaviors of outpatient adults with SCD (time frame: 24 months). 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 18 Sep 2026.