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Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05170412
Recruitment Status : Recruiting
First Posted : December 28, 2021
Last Update Posted : December 7, 2022
Sponsor:
Collaborators:
National Human Genome Research Institute (NHGRI)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

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.


Condition or disease
Sickle Cell Disease

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Observational Study of Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease
Actual Study Start Date : May 26, 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025


Group/Cohort
Patients
outpatient adults with the diagnosis of Sickle Cell Disease



Primary Outcome Measures :
  1. assess the dietary intake and behaviors of outpatient adults with SCD [ Time Frame: 24 months ]
    assess the dietary intake and behaviors of outpatient adults with SCD


Secondary Outcome Measures :
  1. demographic variables related to socioeconomic status, sex, age, birthplace [ Time Frame: 24 months ]
    Identify if associations exist between dietary intake and behaviors

  2. 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. [ Time Frame: 24 months ]
    Identify if associations exist with dietary intake and behaviors with 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.

  3. psychosocial variables of mood, self-esteem, perceived stress, social support, self-mastery, self-compassion, racial identity, and stigmatization as measured by self-reported responses [ Time Frame: 24 months ]
    Identify if associations exist between dietary intake and behaviors with the psychosocial variables of mood, self-esteem, perceived stress, social support, self-mastery, self-compassion, racial identity, and stigmatization as measured by self-reported responses.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
male and female; age: >= 18 years of age; health status: diagnosis of Sickle Cell Disease
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05170412


Contacts
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Contact: Ralph T Tuason, R.N. (301) 594-2212 ralph.tuason@nih.gov
Contact: Nicole M Farmer, M.D. (301) 412-4054 nicole.farmer@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Human Genome Research Institute (NHGRI)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Nicole M Farmer, M.D. National Institutes of Health Clinical Center (CC)
Additional Information:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT05170412    
Other Study ID Numbers: 10000518
000518-CC
First Posted: December 28, 2021    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: October 26, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC):
cross-sectional design
Nutritional Status
physical health
psychosocial health
clinical phenotypes
Natural History
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn