NCT04610827

Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder

Terminated Phase 4 Results posted Last updated 22 May 2024

What this trial tests

Phase 4 trial testing Ferrous sulfate in Sleep Disorder in 6 participants. Terminated before completion.

Timeline

16 November 2020

Primary endpoint
29 June 2021

29 June 2021

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	16 November 2020
Primary completion	29 June 2021
Estimated completion	29 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Ferrous sulfate — full drug profile →

Conditions studied

• Sleep Disorder — all drugs for Sleep Disorder →
• Restless Legs Syndrome — all drugs for Restless Legs Syndrome →
• Periodic Limb Movement Sleep Disorder — all drugs for Periodic Limb Movement Sleep Disorder →
• Iron-deficiency — all drugs for Iron-deficiency →

Sponsor

Mayo Clinic

Who can join

Adults 2 to 10, any sex, with Sleep Disorder or Restless Legs Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ferritin Level Primary · 2 months

Ferritin level in blood measured in micrograms per liter

Group	Value	95% CI
Ferrous Sulfate Twice Daily	24
Ferrous Sulfate Every Other Day	19

Side Effects Primary · 2 months

Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)

Group	Value	95% CI
Ferrous Sulfate Daily	1
Ferrous Sulfate Twice Daily	1
Ferrous Sulfate Every Other Day	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from baseline to end of study participation for a total of approximately 2 months after starting ferrous sulfate on all participants.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ferrous Sulfate Daily

Serious: 0/1 (0%)

Deaths: 0/1

Ferrous Sulfate Twice Daily

Serious: 0/2 (0%)

Deaths: 0/2

Ferrous Sulfate Every Other Day

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (2 terms — click to expand)

Reaction	System	Ferrous Sulfate Daily	Ferrous Sulfate Twice Daily	Ferrous Sulfate Every Othe…
Nausea/GI Upset	Gastrointestinal disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—

Data from ClinicalTrials.gov NCT04610827 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.