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NCT07061470 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep
A Phase 1 study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Not yet
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT07061470: Clinical Trial Phase 1 study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
NCT07061470 is a Phase 1 study that has not yet begun recruiting, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07061470, a Phase 1 study, has not yet begun recruiting, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are: Does 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and/or objectively measured attention more than placebo? Researchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD. Participants will: * Take iron supplements every day for 3 months * Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention * Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment
Primary Outcome
Sleep efficiency refers to the proportion of time in bed spent sleeping and is measured via actigraphy monitoring. Higher scores indicate more efficient/better sleep.
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Ferrous Sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2027-03-01 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
What is known before NCT07061470 opens enrollment
NCT07061470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07061470 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07061470 about?
NCT07061470 is a clinical study titled "A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep". The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are: Does 3 months of iron supplementation treatment impro...
What is the current status of trial NCT07061470?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2027-03-01. Estimated completion is 2027-07-31.
What interventions are being tested in trial NCT07061470?
The interventions under investigation include: Placebo (OTHER), Ferrous Sulfate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07061470?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07061470's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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