Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Optimization of Bioavailability From Iron Supplements: Examinations of Different Supplementation Regimens Including Hepcidin Profiles
Brief Summary: Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The daily supplementation with 1-4 mg Fe/kg body weight for 3 months is reported to be the most effective method to rapidly increase iron stores in subjects with ID and IDA. In IDA patients, medical practitioners often prescribe supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg iron, arguing that the splitting would increase iron bioavailability compared with one single high dose. However, there is no scientific evidence for this assumption; to the contrary, results from a recent study suggest that iron bioavailability from a second supplementation dose of iron after a first supplementation dose of iron is impaired due to increased hepcidin levels. To address this bioavailability issue, the present study will determine iron absorption from 120 mg iron administered for 3 consecutive days and compare it with that from 2 doses of 60 mg iron per day administered for 3 consecutive days. The investigators hypothesize that the iron bioavailability from the single daily dose will be lower than that from the 2 doses. By measuring also hepcidin, this study will provide important insights on the iron bioavailability from a single dose of iron and on the same amount iron split into two doses (b.i.d. administration).


Options:
A: Arm Label: Ferinject (ferric carboxymaltose); Type: EXPERIMENTAL; Interventions: Drug: Ferinject (ferric carboxymaltose) | Arm Label: Standard of Care; Type: OTHER; Interventions: Other: Standard of Care | Intervention Type: DRUG; Name: Ferinject (ferric carboxymaltose); Assigned to Arm(s): Ferinject (ferric carboxymaltose) | Intervention Type: OTHER; Name: Standard of Care; Assigned to Arm(s): Standard of Care
B: Arm Label: Ferinject (ferric carboxymaltose); Type: EXPERIMENTAL; Interventions: Drug: Ferinject (ferric carboxymaltose) | Arm Label: Placebo (saline); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (saline) | Intervention Type: DRUG; Name: Ferinject (ferric carboxymaltose); Assigned to Arm(s): Ferinject (ferric carboxymaltose) | Intervention Type: DRUG; Name: Placebo (saline); Assigned to Arm(s): Placebo (saline)
C: Intervention Type: DRUG; Name: Iron Sucrose IV 200mg, once a week, for 5 weeks; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Ferrous sulfate 200mg PO TID, for 8 weeks; Assigned to Arm(s): N/A
D: Arm Label: Single oral iron supplement per day (120 mg); Type: EXPERIMENTAL; Interventions: Dietary Supplement: Single oral iron dose of 120 mg per day for 3 consecutive days | Arm Label: B.i.d. oral iron supplement (2x 60 mg); Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days | Intervention Type: DIETARY_SUPPLEMENT; Name: Single oral iron dose of 120 mg per day for 3 consecutive days; Assigned to Arm(s): Single oral iron supplement per day (120 mg) | Intervention Type: DIETARY_SUPPLEMENT; Name: Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days; Assigned to Arm(s): B.i.d. oral iron supplement (2x 60 mg)

Answer: D