Conditions: Anemia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 594
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Detailed description:
Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Arms:
arm 1: Day 0: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.

Day 7: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. arm 2: Day 0: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously.

Day 7: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.

Interventions: intervention 1: VIT-45 intervention 2: Placebo
Intervention descriptions: intervention 1: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously intervention 2: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously

Protocol document: