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Impact of Iron Supplementation Treatment on Brain Iron Concentrations

NCT04144790 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2025-10-14

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

ferrous sulfate

Although established guidelines do not currently exist for iron supplementation for children, studies have demonstrated effectiveness of a 3-month treatment regimen of 5mg/kg per day of orally-administered ferrous sulfate in reducing PLMS and subjective RLS symptoms and in increasing serum ferritin levels. Ferrous sulfate 80 mg/day resulted in improvement of ADHD symptoms in iron-deficient children.

Sponsors & Collaborators

  • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04144790 on ClinicalTrials.gov