Actively Recruiting

Phase 4
Age: 16Years - 60Years
FEMALE
Healthy Volunteers
NCT05929729

Iron Deficiency Anemia (IDA) and the Brain

Led by Children's Hospital Los Angeles · Updated on 2024-10-30

120

Participants Needed

4

Research Sites

247 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital Los Angeles

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Iron Deficiency Anemia (IDA) and the Brain

Who Can Participate

Age: 16Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 16 and 60 years
  • Female gender
  • Any ethnicity
  • For anemic group: hemoglobin 6410.5 g/dl or hematocrit <32% from finger prick or plethysmography test, or <11 g/dl from venipuncture blood draw
  • For control group: hemoglobin >13.2 g/dl or hematocrit >39.6%
  • For interventional arm: diagnosis of iron deficiency anemia confirmed by hematologist based on transferrin saturation, ferritin, and other lab tests including hs-CRP, MMA, and hemoglobin electrophoresis
Not Eligible

You will not qualify if you...

  • Diabetes requiring medication
  • Hypertension requiring medication
  • Sleep disordered breathing requiring intervention
  • Body mass index >40 (morbid obesity)
  • Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy
  • Known systemic inflammatory diseases such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma
  • Known HIV infection
  • For interventional arm: prior reaction to intravenous iron
  • History of multiple drug allergies
  • History of severe asthma, eczema, or atopy
  • Systemic mastocytosis
  • Severe respiratory or cardiac disease
  • No access to a physician who can manage iron deficiency anemia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

City of Hope Blood Donor Center

Duarte, California, United States, 91010

Not Yet Recruiting

2

Cedar Sinai Blood Bank

Los Angeles, California, United States, 90027-6062

Not Yet Recruiting

3

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

4

University of California, Los Angeles Blood Donor Center

Los Angeles, California, United States, 90095

Not Yet Recruiting

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Research Team

S

Silvie Suriany, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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