Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease

NCT05170412 | Recruiting

• 2 other identifiers: 10000518000518-CC
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sickle Cell Disease

Keywords

cross-sectional design; Nutritional Status; physical health; psychosocial health; clinical phenotypes; Natural History

Outcome Measures

Primary Outcomes (1)

• assess the dietary intake and behaviors of outpatient adults with SCD

  assess the dietary intake and behaviors of outpatient adults with SCD

  24 months

Secondary Outcomes (3)

• demographic variables related to socioeconomic status, sex, age, birthplace

  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.

  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

  24 months

Study Arms (1)

Patients

outpatient adults with the diagnosis of Sickle Cell Disease

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

male and female; age: \>= 18 years of age; health status: diagnosis of Sickle Cell Disease

You may qualify if:

• 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
• 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+

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Human Genome Research Institute (NHGRI): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Anemia, Sickle Cell

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

Study Officials

• Nicole M Farmer, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie L Wildridge, R.N.

CONTACT

(240) 927-2603; wildridgesl@mail.nih.gov

Nicole M Farmer, M.D.

CONTACT

(301) 412-4054; nicole.farmer@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: December 28, 2021
• Study Start: May 26, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04-09

Locations

US (1)