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 present study will test whether the fractional and total iron absorption from iron supplements (60 mg) administered daily for 14 days differs from that of iron supplements (60 mg) administered every second day for 28 days. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole supplementation period. We hypothesize that the fractional and total iron absorption from the daily administration of 60 mg is lower than that from the administration on every second day due to increased SHep levels when supplements are administered daily.

The study will provide important insights about the optimization of iron bioavailability from different supplementation regimens including the performance of SHep, a key regulator of human iron metabolism.


Options:
A: Arm Label: Injectafer; Type: EXPERIMENTAL; Interventions: Drug: Injectafer | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Injectafer; Assigned to Arm(s): Injectafer | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Oral iron supplement every day for 14 days; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days | Arm Label: Oral iron supplement every second day for 28 days; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days | Intervention Type: DIETARY_SUPPLEMENT; Name: Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days; Assigned to Arm(s): Oral iron supplement every day for 14 days | Intervention Type: DIETARY_SUPPLEMENT; Name: Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days; Assigned to Arm(s): Oral iron supplement every second day for 28 days
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Ferinject ® (Ferric carboxymaltose) | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Normal saline (0.9%) | Intervention Type: DRUG; Name: Ferinject ® (Ferric carboxymaltose); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Normal saline (0.9%); Assigned to Arm(s): 2
D: Arm Label: Ferinject; Type: EXPERIMENTAL; Interventions: Drug: Ferinject | Arm Label: Saline; Type: PLACEBO_COMPARATOR; Interventions: Other: Saline | Intervention Type: DRUG; Name: Ferinject; Assigned to Arm(s): Ferinject | Intervention Type: OTHER; Name: Saline; Assigned to Arm(s): Saline

Answer: B