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Protocol Details

Observational Study of Dietary Intake and Dietary Behaviors in Adults with Sickle Cell Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000518-CC

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women;
Non-English Speaking;
Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Sickle Cell Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Human Genome Research InstituteNIH Clinical CenterNational Heart, Lung and Blood Institute

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.

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Eligibility

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Nicole M. Farmer, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 3C440
10 CENTER DR
BETHESDA MD 20892
(301) 412-4054
nicole.farmer@nih.gov

Stephanie L. Wildridge, R.N.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 2B07B4
10 CENTER DR
BETHESDA MD 20892
(240) 927-2603
wildridgesl@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05170412

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