Recruiting

Observational Study

Sponsor:

NIH

Code:

NCT05170412

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05170412

Start date

May 26, 2022

Status verified date

Aug 26, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients

outpatient adults with the diagnosis of Sickle Cell Disease

Primary outcome measure

  • assess the dietary intake and behaviors of outpatient adults with SCD [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Stephanie L Wildridge, R.N.

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

Nicole M Farmer, M.D.

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

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institutes of Health Clinical Center (CC)

Last update posted

Sep 3, 2026

Last verified

Aug 26, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC) on 2026-09-03.