Last reviewed · How we verify
NCT04144790
Impact of Iron Supplementation Treatment on Brain Iron Concentrations
trial testing ferrous sulfate in ADHD in 12 participants. Completed in 30 June 2025.
30 June 2025
Quick facts
| Lead sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 12 |
| Start date | 15 September 2022 |
| Primary completion | 30 June 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ferrous sulfate — full drug profile →
Conditions studied
- ADHD — all drugs for ADHD →
- Iron-deficiency — all drugs for Iron-deficiency →
- Restless Legs Syndrome — all drugs for Restless Legs Syndrome →
- Periodic Limb Movement Sleep Disorder — all drugs for Periodic Limb Movement Sleep Disorder →
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Who can join
Adults 5 to 18, any sex, with ADHD or Iron-deficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04144790
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for ADHD
Currently open trials in the same condition.
- NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body · Phase 1 · recruiting
- NCT07262853 — Dual Executive Function Training Package · NA · recruiting
- NCT07291453 — Loving Habits: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits · NA · recruiting
- NCT07281092 — Comparative Efficacy of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) · NA · recruiting
- NCT07219810 — Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD · NA · recruiting
Other Hugo W. Moser Research Institute at Kennedy Krieger, Inc. trials
Trials by the same sponsor.
- NCT07221968 — Melatonin for the Treatment of DEE-SWAS · Phase 2 · not yet recruiting
- NCT07061470 — A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep · Phase 1, PHASE2 · not yet recruiting
- NCT06915480 — Reducing Missed Appointments · Phase 3 · recruiting
- NCT07278388 — Neural Mechanisms of Fatigue in Post-Acute Sequela of SARS-CoV-2 · NA · recruiting
- NCT06810180 — Examination of the Dynamic Relationships of Sleep, Physical Activity, and Circadian Rhythmicity With Neurobehavioral Het · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04144790 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Last refreshed: 14 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04144790.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing