Recruiting

Observational Study

Sponsor:

Children's Hospital Los Angeles

Code:

NCT05929729

Conditions

IDA - Iron Deficiency Anemia

Anemia

Iron Deficiency Anemia

Anemia, Iron Deficiency

Eligibility Criteria

Sex: Female

Age: 16 - 60

Healthy Volunteers: Accepted

Interventions

Ferric derisomaltose

NovaFerrum

Study Details

Brief summary:

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

IDA - Iron Deficiency Anemia

Anemia

Iron Deficiency Anemia

Anemia, Iron Deficiency

Study ID

NCT05929729

Start date

Dec 7, 2023

Status verified date

Jul, 2024

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Observational arm:

1. Age between 16 and 60 years of age.
2. Any ethnicity.
3. Female
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
5. Control group: hemoglobin >13.2 g/dl or hematocrit >39.6%
  • Interventional arm:

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, hemoglobin electrophoresis

Exclusion Criteria:

  • Observational arm:

1. Diabetes requiring medication.
2. Hypertension requiring medication.
3. Sleep disordered breathing requiring intervention.
4. Body mass index >40 (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.
  • Interventional arm:

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.
7. Having no access to a physician who can manage the iron deficiency anemia.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Intravenous (IV) iron

This group will receive intravenous iron (Ferric Derisomaltose) in a single dose of 20 mg/kg (max individual dose of 1000 mg). The drug is administered as an infusion over 30 minutes. 3 months after the infusion, they will receive a 9-month supply of Novaferrum pill to be taken once a day.

no intervention: Standard of care iron

This group will be referred to their primary care provider for oral iron therapy. If a participant cannot obtain care from a physician

no intervention: Healthy Controls

This group will only be participating in the observational part of the study and serve as our controls.

Interventions

Ferric derisomaltose

Refer to arm/group descriptions

NovaFerrum

Refer to arm/group descriptions

Primary outcome measure

  • Impact of iron deficiency anemia on regional cerebrovascular oxygen delivery (ml O2/100g/min). [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on regional cerebrovascular oxygen delivery (ml O2/100g/min) in iron deficiency anemia at day 90 post therapy [ Time Frame: Day 90 post-iron-therapy ]
  • Impact of iron therapy on regional cerebrovascular oxygen delivery (ml O2/100g/min) in iron deficiency anemia at day 365 post therapy. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on cerebrovascular flow reactivity (%SI change/%ETCO2) [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on cerebrovascular flow reactivity (%SI change/%ETCO2) in people with iron deficiency anemia at 90 days post iron therapy. [ Time Frame: Day 90 post iron therapy ]
  • Impact of iron therapy on cerebrovascular flow reactivity (%SI change/%ETCO2) in people with iron deficiency anemia at day 365. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on blood brain barrier permeability surface area product (ml H20/100g/min) [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on blood brain barrier permeability surface area product (ml H20/100g/min) in iron deficiency anemia will be assessed at 90 days. [ Time Frame: Day 90 post iron therapy ]
  • Impact of iron therapy on blood brain barrier permeability surface area product (ml H20/100g/min) in iron deficiency anemia will be assessed again at day 365. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on cerebral metabolic rate of oxygen (ml O2/100g/min). [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on cerebral metabolic rate of oxygen (ml O2/100g/min) in people with iron deficiency anemia at day 90 post iron therapy. [ Time Frame: Day 90 post iron therapy ]
  • Impact of iron therapy on cerebral metabolic rate of oxygen (ml O2/100g/min) in people with iron deficiency anemia at day 365 post iron therapy. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on total brain blood flow (ml blood/100g/min). [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on total brain blood flow (ml blood/100g/min) in people with iron deficiency anemia at day 90 [ Time Frame: Day 90 post iron therapy ]
  • Impact of iron therapy on total brain blood flow (ml blood/100g/min) in people with iron deficiency anemia at day 365 [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on visual-motor integration. [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on visual-motor integration in people with iron deficiency anemia. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on sustained attention. [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on sustained attention in people with iron deficiency anemia. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on working memory function. [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on working memory function in people with iron deficiency anemia. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on the ability to inhibit cognitive interference [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on the ability to inhibit cognitive interference in people with iron deficiency anemia. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on fine motor control. [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on fine motor control in people with iron deficiency anemia. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron therapy on list learning and recall task in people with iron deficiency anemia. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on visuospatial memory [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on visuospatial memory in people with iron deficiency anemia. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on general intellectual functioning, verbal and nonverbal abilities. [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on general intellectual functioning, verbal and nonverbal abilities in people with iron deficiency anemia. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on cognitive flexibility and processing speed. [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on cognitive flexibility and processing speed in people with iron deficiency anemia. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on list learning and recall task [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron deficiency anemia on emotional health [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on emotional health in people with iron deficiency anemia. [ Time Frame: Day 365 post iron therapy ]
  • Impact of iron deficiency anemia on executive functions in day-to-day life. [ Time Frame: Day 0 (observation arm) ]
  • Impact of iron therapy on executive functions in day-to-day life in people with iron deficiency anemia. [ Time Frame: Day 365 post iron therapy ]

Central Contacts and Locations

Central contacts

Silvie Suriany, MSc

323-361-4783anemia@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Silvie Suriany, MSc

323-361-4783anemia@chla.usc.edu

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Oct 30, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2024-10-30.