drugset / Trial / NCT06437080

Hypoferritinemia Without Anemia Among Reproductive Age Females

NCT06437080

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this randomized controlled trial is to compare the treatment outcomes of oral iron supplementation (Group A) versus Intravenous (IV) iron supplementation (Group B) versus no treatment (Group C) on the serum ferritin level and to determine the outcomes in the severity of symptoms of HWA, among reproductive age females (age 18-45) with hypoferritinemia without Anemia (HWA), after four months of the start of the intervention. Participants will: * Randomly divided into 3 groups (A, B and C) to receive treatment. * 100 patients will be allocated to each of the three study groups i.e., group A, B and C. The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg (Fersip) daily for three months, participants of group B will get IV Ferric Carboxymaltose (Ferinject) for 03 months (3 doses) and Group C will get no treatment.

Timeline

Start
2022-10-10
Primary completion
2025-10-16
Completion
2025-10-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferric carboxymaltose Other / unclassified 50 mg/ml Intravenous
Comparator Iron III Hydroxide Polymaltose Complex Unknown 100 mg Oral