Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease
Recruiting · NCT05170412 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Institutes of Health Clinical Center (CC)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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+
Exclusion criteria
- 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
Where it is running
1 location listed across 1 US state.
- National Institutes of Health Clinical Center - Bethesda, Maryland, United States