Iron Supplementation for ADHD and Restless Sleep

Overseen By Alison E Pritchard, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Must be taking: Iron supplements

Disqualifiers: Chronic conditions, Sleep apnea, Anemia, others

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if iron supplements, specifically ferrous sulfate, can reduce restless sleep and improve ADHD symptoms in young people. Participants will receive either iron supplements or a placebo (a harmless look-alike pill) for three months. The study evaluates whether iron aids sleep issues and attention, using reports from parents and wearable sleep trackers. It suits those diagnosed with ADHD who experience restless sleep and have low iron levels in their blood. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that iron supplements, particularly ferrous sulfate, are generally well-tolerated. Studies have found that iron can help with restless sleep and ADHD symptoms, which are linked to low iron levels. Notably, a review found that iron supplements were beneficial in 29 out of 30 studies on restless leg syndrome and other sleep problems.

While iron supplements are widely used and generally safe, some people might experience minor side effects like an upset stomach or constipation. Iron supplements have been safely used for other conditions, and current research aims to confirm their safety and effectiveness for treating sleep issues and ADHD symptoms in young people. Potential participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ADHD and restless sleep, which often include medications like stimulants or non-stimulant medications, iron supplementation with ferrous sulfate offers a unique approach by addressing potential nutritional deficiencies. Researchers are excited about this treatment because low iron levels have been linked to symptoms of ADHD and poor sleep quality, and supplementing with iron might directly improve these conditions. This approach not only targets the symptoms but also addresses an underlying deficiency, potentially offering a more holistic and sustainable improvement.

What evidence suggests that iron supplementation might be an effective treatment for ADHD and restless sleep?

Research has shown that iron supplements can improve ADHD symptoms, such as difficulty paying attention, hyperactivity, and impulsivity. One study found that iron benefited children with ADHD who had low iron levels. Other research suggests that iron may also alleviate sleep problems, like restless sleep, often associated with ADHD. Iron plays a crucial role in brain health and may aid in regulating sleep patterns. In this trial, participants in the iron supplementation group will receive iron supplements to assess their effectiveness in managing both ADHD symptoms and sleep issues in young people. ^{1 2 3 6 7}

Who Is on the Research Team?

Alison E Pritchard, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for young people with ADHD who also have restless sleep. They should not be currently receiving iron supplements or treatment for restless legs syndrome. Participants must be willing to take a daily supplement and visit the clinic twice, as well as wear motion-monitoring leg bands during sleep before and after the treatment period.

Inclusion Criteria

Blood ferritin level below 50ng/mL

Clinically diagnosed with ADHD

I often have trouble sleeping restlessly.

Exclusion Criteria

I have taken iron supplements in the last 3 months.

I have moderate to severe sleep apnea.

I have a chronic or genetic condition affecting my iron levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-treatment Monitoring

Participants wear motion-monitoring leg bands for 2 weeks and complete baseline assessments

2 weeks

1 visit (in-person)

Treatment

Participants receive daily iron supplementation or placebo for 3 months

12 weeks

1 visit (in-person) at the end of treatment

Post-treatment Monitoring

Participants wear motion-monitoring leg bands for 2 weeks and complete post-treatment assessments

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ferrous Sulfate

Trial Overview The study tests if taking iron supplements (Ferrous Sulfate) every day for 3 months can improve sleep difficulties and attention in youth with ADHD compared to a placebo. It involves clinic visits, daily supplementation, and wearing motion-monitoring devices during sleep at two different times.

How Is the Trial Designed?

Group I: Iron supplementation arm Experimental Treatment 1 Intervention

Participants in the iron supplementation arm will receive 3 months of iron supplementation treatment

Group II: Placebo arm Placebo Group 1 Intervention

Participants in the placebo arm will receive 3 months of placebo treatment

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

93

Recruited

25,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07061470

A Clinical Trial of Iron Supplementation for Youth With ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8553525/

Effects of Iron Supplementation on Attention Deficit ... All these results support the hypothesis that Iron supplementation may help the improvement of ADHD symptoms especially in conduct subscale. It ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0887899407004171

Effects of Iron Supplementation on Attention Deficit ... Iron supplementation (80 mg/day) appeared to improve ADHD symptoms in children with low serum ferritin levels suggesting a need for future investigations with ...

4. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.neuropsych.20230081

Systematic Review, Meta-Analysis, and Qualitative Synthesis Both documented improvement in ADHD symptoms (inattention, hyperactivity, and impulsivity) after administration of iron supplementation (32, 41) ...

5. mdpi.com mdpi.com/2514-183X/7/3/18

Restless Sleep Disorder and the Role of Iron in Other ... In this narrative review, we discuss the role of iron in sleep-related movement disorders, as well as ADHD, highlighting not only the connection between these ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079220300174

Iron deficiency and sleep – A scoping review Iron supplementation was beneficial in 29/30 RLS (including five randomized controlled trials [RCTs]), 1/1 SDB, and 2/2 GSD treatment studies. Iron ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04144790

Impact of Iron Supplementation Treatment on Brain ... The investigators hypothesize that iron supplementation treatment will result in decreased symptoms of ADHD and restlessness during sleep. Aim 3 is to ...