Overview

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

Status:
Enrolling by invitation
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Criteria
Inclusion Criteria:

- Ferritin equal to or lower than 24 mcg/L drawn within the last 30 days.

- Age 2 to 8 years.

- Diagnosis of restless leg syndrome, periodic limb movement disorder, or sleep
disturbance.

Exclusion Criteria:

- Currently taking oral formulation of iron other than a multivitamin.

- Untreated obstructive sleep apnea.

- Gastrointestinal disorder, including gastroesophageal refluex 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.