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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 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.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07061470
The ClinicalTrials.gov registry entry for NCT07061470 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07061470 reports 0 study locations.
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.
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