Summary

Eligibility
for people ages 16-60 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Dawn Ward, MD (ucla)

Description

Summary

This is an observational trial, in patients with moderate to severe anemia and control subjects. The main purpose of this study is to understand whether normal brain blood flow, oxygen extraction reserve, white matter volumes, and brain functional connectivity are affected by acquired anemia. The investigators will perform baseline MRI monitoring for all subjects. S All eligible subjects will be asked to provide informed consent before participating in the study.

Details

This is an observational trial, in patients with moderate to severe anemia and control subjects. The main purpose of this study is to understand whether normal brain blood flow, oxygen extraction reserve, white matter volumes, and brain functional connectivity are affected by acquired anemia. The investigators will perform baseline MRI monitoring for all subjects. All eligible subjects will be asked to provide informed consent before participating in the study. Comprehensive cerebrovascular MRI, baseline bloodwork, and neurocognitive testing will be collected from all subjects.

Keywords

Anemia Iron-deficiency Anemia Healthy Controls Anemia, Iron-Deficiency Acquired Anemia

Eligibility

You can join if…

Open to people ages 16-60

(observational component):

  1. Age between 16 and 60 years of age.
  2. Any ethnicity.
  3. Either sex.
  4. Anemic group: hemoglobin less than 10.5 g/dl on screening hemoglobin.
  5. Control group: hemoglobin >13.2 g/dl for females, >14.6 g/dl for males, comparable age, sex and ethnicity to currently enrolled anemic subjects.

You CAN'T join if...

(observational component):

  1. Diabetes requiring medication.
  2. Hypertension requiring medication.
  3. Sleep disordered breathing requiring intervention.
  4. Body mass index >35 (morbid obesity)
  5. Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.
  6. Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma.
  7. Known HIV.

Inclusion criteria (interventional component):

  1. Criteria for observational component, plus
  2. Iron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA.

Exclusion criteria (interventional component):

  1. Criteria for observational component, plus
  2. Prior reaction to intravenous iron.
  3. History of multiple drug allergies.
  4. History of severe asthma, eczema, or atopy.
  5. Systemic mastocytosis.
  6. Severe respiratory or cardiac disease.

Locations

  • University of California, Los Angeles Blood Donor Center not yet accepting patients
    Los Angeles California 90095 United States
  • Cedar Sinai Blood Bank not yet accepting patients
    Los Angeles California 90027-6062 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States

Lead Scientist at University of California Health

  • Dawn Ward, MD (ucla)
    HS Assistant Clinical Professor, Pathology and Laboratory Medicine. Authored (or co-authored) 12 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Hospital Los Angeles
ID
NCT04320966
Study Type
Observational
Last Updated