Anemia, Iron Deficiency
Conditions
Brief summary
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia.
Detailed description
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia. The two dosing regimens under review are a low dose weekly or a larger dose given every three weeks.
Interventions
DRUGIV iron
IV iron infusion based on weekly or every 3 week dosage.
Sponsors
Sutter Gould Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients over the age of 18 years old. 2. Being treated by a Sutter Health Physician. 3. Hemoglobin of \< 10mg/dl for Men and Women 4. Ferritin \</= 10ng/ml 5. Patients in whom oral administration is unsatisfactory or impossible.
Exclusion criteria
1. Patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable. 2. Anemia due to acute blood loss; menorrhagia is allowed. 3. Patients with a current illness known to interact with iron status. 4. Patients unwilling to consent to required blood draws. 5. Patients who are viewed as unable to complete treatment, based on PI recommendation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| superior dosing regimen exists for INfed | 3 years | shown by a 2gm/dl increase in HgB |
| High Dose Effect | 3 years | INfed can be given at high dose without an increase in AE and/or SAEs frequency |
Countries
United States
Outcome results
None listed