NCT05170412 Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease
| NCT ID | NCT05170412 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institutes of Health Clinical Center (CC) |
| Condition | Sickle Cell Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-05-26 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2022-05-26 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, the participant must: 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: The following criteria will exclude any individual from participating in the study: 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
Contact & Investigator
Nicole M Farmer, M.D.
PRINCIPAL INVESTIGATOR
National Institutes of Health Clinical Center (CC)
Frequently Asked Questions
Who can join the NCT05170412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05170412 currently recruiting?
Yes, NCT05170412 is actively recruiting participants. Contact the research team at wildridgesl@mail.nih.gov for enrollment information.
Where is the NCT05170412 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05170412 clinical trial?
NCT05170412 is sponsored by National Institutes of Health Clinical Center (CC). The principal investigator is Nicole M Farmer, M.D. at National Institutes of Health Clinical Center (CC). The trial plans to enroll 80 participants.
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