RECRUITING

Iron Deficiency Anemia (IDA) and the Brain

Talk to us

Conditions

IDA - Iron Deficiency AnemiaAnemiaIron Deficiency AnemiaAnemia, Iron Deficiency

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a trial with an observational and an interventional arm, in patients with moderate to severe anemia and control subjects. The main purposes of this study is to phenotype the scope of neurocognitive deficits from iron deficiency anemia (IDA) in adult women, determine derangements in cerebral perfusion, vascular reactivity, functional connectivity, and blood brain barrier permeability in adult-onset IDA and relate them to neurocognitive deficits, as well as determine the reversibility and durability of both the physiologic and neurocognitive derangements by iron replacement therapy. All eligible subjects will be asked to provide informed consent before participating in the study.

Official Title

Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia

Quick Facts

Study Start:2023-12-07
Study Completion:2028-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05929729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Observational arm:
  2. 1. Age between 16 and 60 years of age.
  3. 2. Any ethnicity.
  4. 3. Female
  5. 4. Anemic group: hemoglobin ≤10.5 g/dl or hematocrit \<32% from finger prick or plethysmography test, or \<11 g/dl from venipuncture blood draw
  6. 5. Control group: hemoglobin \>13.2 g/dl or hematocrit \>39.6%
  7. * Interventional arm:
  8. 1. Criteria for observational component, plus
  9. 2. Iron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA, hemoglobin electrophoresis
  1. * Observational arm:
  2. 1. Diabetes requiring medication.
  3. 2. Hypertension requiring medication.
  4. 3. Sleep disordered breathing requiring intervention.
  5. 4. Body mass index \>40 (morbid obesity)
  6. 5. Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.
  7. 6. Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma.
  8. 7. Known HIV.
  9. * Interventional arm:
  10. 1. Criteria for observational component, plus
  11. 2. Prior reaction to intravenous iron.
  12. 3. History of multiple drug allergies.
  13. 4. History of severe asthma, eczema, or atopy.
  14. 5. Systemic mastocytosis.
  15. 6. Severe respiratory or cardiac disease.
  16. 7. Having no access to a physician who can manage the iron deficiency anemia.

Contacts and Locations

Study Contact

Silvie Suriany, MSc
CONTACT
323-361-4783
anemia@chla.usc.edu

Principal Investigator

John Wood, MD, PhD
PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles

Study Locations (Sites)

City of Hope Blood Donor Center
Duarte, California, 91010
United States
Cedar Sinai Blood Bank
Los Angeles, California, 90027-6062
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
University of California, Los Angeles Blood Donor Center
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Children's Hospital Los Angeles

  • John Wood, MD, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-07
Study Completion Date2028-09-01

Study Record Updates

Study Start Date2023-12-07
Study Completion Date2028-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • IDA - Iron Deficiency Anemia
  • Anemia
  • Iron Deficiency Anemia
  • Anemia, Iron Deficiency