A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study ID
NCT07061470
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Ferrous Sulfate — DIETARY_SUPPLEMENT
    Dosing of the iron supplement will be based on weight.
  • Placebo — OTHER
    Placebo pills will be provided to participants in the placebo arm

Study Details

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

Key Dates

Start date
Mar 1, 2027
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Iron supplementation arm
    Participants in the iron supplementation arm will receive 3 months of iron supplementation treatment
  • Placebo Comparator: Placebo arm
    Participants in the placebo arm will receive 3 months of placebo treatment

Primary Outcome Measure

Sleep Efficiency [ Time Frame: Sleep efficiency will be assessed nightly for 2 weeks before treatment begins and then again for 2 weeks at the end of treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kennedy Krieger InstituteBaltimoreMaryland21231
Alison E Pritchard, PhD
[email protected]
443-904-2488

Find similar trials in Baltimore, MD

By condition
ADHD
By specialty
PsychiatryMental healthBehavioral health
By research site
Kennedy Krieger Institute· Baltimore, MD

Related Studies