To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS)
symptoms and brain concentrations of iron.
- Clinical diagnosis of Restless Legs Syndrome (RLS).
- Presence of increased PLMS before receiving treatment.
- Patient sleep times are between 9pm and 9am.
- Patient's RLS symptoms would occur daily if you were not on medication.
- RLS secondary to other medical disorders as determined by history and
- On a treatment (e.g., psychiatric medication) that might significantly alter RLS
symptoms or study results and who cannot discontinue medication for the extended
period of the study.
- History of multiple adverse drug reactions or specifically an allergy to IV iron.
- Currently experiencing a serious medical condition (chronic organ failure, active
inflammation or infection, congestive heart failure, etc.) that might alter iron
metabolism, would place them at risk, or interfere with study participation.
- An MRI is not possible because of medical reasons (Pacemaker; loose iron in the
tissue) or concern about severe claustrophobia.
- Any condition that is likely to increase iron loss (chronic bleeding, excluding
menstruation; medically necessary phlebotomy) or consumption (pregnancy).
- Serum ferritin >300mg/L or percent iron saturation >50%. This is to exclude subjects
with probable hemochromatosis.
- Significant medical (e.g., inflammatory bowel syndrome; bowel dysmotility syndromes)
or surgical (e.g., gastrojejunal bypass, colectomy) GI tract problems; and active
chronic inflammatory processes (e.g., active hepatitis, rheumatoid arthritis, SLE).
This is to exclude conditions which will potentially alter iron metabolism.