Sleep DisorderPhase 4NCT04610827
Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder
A Phase 4 study testing Ferrous sulfate in people with Sleep Disorder and Restless Legs Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Sleep Disorder, Restless Legs Syndrome, Periodic Limb Movement Sleep Disorder
- What is being tested?
- Ferrous sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 29 Jun 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ferritin equal to or lower than 24 mcg/L drawn within the last 30 days.
- Age 2 to 10 years.
- Diagnosis of restless leg syndrome, periodic limb movement disorder, or sleep disturbance.
Who cannot join
- Currently taking oral formulation of iron other than a multivitamin.
- Untreated obstructive sleep apnea.
- Gastrointestinal disorder, including gastroesophageal reflux disease and celiac disease.
- Prior gastrointestinal surgery; e.g., gastrectomy, duodenal bypass, and presence of G-tube.
- Use of H2 blocker, antacid, or proton pump inhibitor.
- Inflammatory disorders, including juvenile idiopathic arthritis or inflammatory bowel disease.
- Elevated CRP at time of initial ferritin or report of illness in past 4 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Optimum Frequency and Timing of Oral Iron Administration for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder
The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.
- Conditions
- Sleep Disorder, Restless Legs Syndrome, Periodic Limb Movement Sleep Disorder, Iron-deficiency
- Being tested
- Ferrous sulfate
- Medical subject headings
- Sleep Wake Disorders, Restless Legs Syndrome, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfateDrug
Guideline-recommended 3 mg/kg/day dosing
| Study group | Role | What they receive |
|---|---|---|
| Ferrous sulfate daily | Active comparator | Subject will take 3 mg/kg oral iron in the morning Receives: Drug: Ferrous sulfate |
| Ferrous sulfate twice daily | Active comparator | Subjects will take 1.5 mg/kg oral iron twice daily Receives: Drug: Ferrous sulfate |
| Ferrous sulfate every other day | Active comparator | 6 mg/kg oral iron every other day in the morning Receives: Drug: Ferrous sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin Level
Ferritin level in blood measured in micrograms per liter
Measured: 2 months
Side Effects
Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start16 Nov 2020
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Why it stopped: Change in personnel and lack of resources to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie M. Baughn, Mayo Clinic
- Investigators
- Julie Baughn, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610827
- Sponsor's protocol ID
- 20-007655
- Status last verified
- May 2024
- First submitted
- 26 Oct 2020
- Last updated
- 22 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimum Frequency and Timing of Oral Iron Administration for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder
- ClinicalTrials.gov ID
- NCT04610827
- Acronym / sponsor ID
- 20-007655
- Conditions
- Sleep Disorder, Restless Legs Syndrome, Periodic Limb Movement Sleep Disorder, Iron-deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in personnel and lack of resources to continue.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Posted 22 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ferrous sulfate daily | Active comparator | Drug: Ferrous sulfateSubject will take 3 mg/kg oral iron in the morning |
| Ferrous sulfate twice daily | Active comparator | Drug: Ferrous sulfateSubjects will take 1.5 mg/kg oral iron twice daily |
| Ferrous sulfate every other day | Active comparator | Drug: Ferrous sulfate6 mg/kg oral iron every other day in the morning |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ferritin equal to or lower than 24 mcg/L drawn within the last 30 days.
- Age 2 to 10 years.
- Diagnosis of restless leg syndrome, periodic limb movement disorder, or sleep disturbance.
Key exclusion criteria (7 listed)
- Currently taking oral formulation of iron other than a multivitamin.
- Untreated obstructive sleep apnea.
- Gastrointestinal disorder, including gastroesophageal reflux disease and celiac disease.
- Prior gastrointestinal surgery; e.g., gastrectomy, duodenal bypass, and presence of G-tube.
- Use of H2 blocker, antacid, or proton pump inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous sulfateGuideline-recommended 3 mg/kg/day dosing | Drug | Ferrous sulfate daily, Ferrous sulfate every other day, Ferrous sulfate twice daily |
Primary outcome
Ferritin Level
Time frame: 2 months
Ferritin level in blood measured in micrograms per liter
Side Effects
Time frame: 2 months
Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Baughn, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferrous sulfate in people with Sleep Disorder and Restless Legs Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ferritin Level (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.