RECRUITING

Impact of Iron Supplementation Treatment on Brain Iron Concentrations

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

The goal of the present study is to provide novel data to evaluate brain iron concentration as a mediator of the association between iron supplementation treatment and improvement in symptoms of ADHD and RLS in children, including PLMS. Twelve participants between the ages of 10 and 15 years will be recruited via Kennedy Krieger Institute's Sleep Disorders Clinic. Eligible participants will be asked to complete, at baseline (pre-iron supplementation treatment) and again at follow-up (post-treatment): 1) a 7 Tesla MRI scan, 2) five consecutive nights of RestEaZe™ monitoring, 3) caregiver-reported (or patient-reported if over the age of 10 years) International Restless Leg Syndrome Scale (IRLSS), and 4) caregiver-reported ADHD Rating Scale-5. The treatment interval will be 3 months.

Official Title

Impact of Iron Supplementation Treatment on Brain Iron Concentrations Among Children With ADHD & Restless Leg Syndrome Combined With Periodic Limb Movements in Sleep

Quick Facts

Study Start:2022-09-15
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04144790

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:5 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * a clinical diagnosis of RLS
  2. * a clinical diagnosis of ADHD
  3. * PLMS \> 3/hour, based on average of 5 nights of home recording with RestEaze leg meters
  4. * fasting serum iron values with ferritin \< 50 mcg/kg and transferrin saturation \< 45%
  1. * family is not proficient in English language
  2. * child is in foster care
  3. * child has a chronic medical condition or genetic/metabolic disorder that might impact iron metabolism
  4. * child has another sleep disorder or neuropsychiatric condition that might influence sleep, RLS, or ADHD symptoms
  5. * child has been receiving iron supplementation, psychostimulant treatment, or a dopamine agonist within the past 6 months.

Contacts and Locations

Study Contact

Alison E Pritchard, PhD
CONTACT
443-923-4409
pritchard@kennedykrieger.org

Principal Investigator

Alison E Pritchard, PhD
PRINCIPAL_INVESTIGATOR
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Locations (Sites)

Kennedy Krieger Institute
Baltimore, Maryland, 21231
United States

Collaborators and Investigators

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  • Alison E Pritchard, PhD, PRINCIPAL_INVESTIGATOR, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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 Date2022-09-15
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-09-15
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • ADHD
  • Iron-deficiency
  • Restless Legs Syndrome
  • Periodic Limb Movement Sleep Disorder