Hypoferritinemia Without Anemia Among Reproductive Age Females
Status:
ACTIVE_NOT_RECRUITING
Trial end date:
2025-04-01
Target enrollment:
Participant gender:
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 normal diet (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.
The main questions it aims to answer are:
1. What are the main determinants of HWA?
2. There is no difference/ difference in the treatment outcomes after intervention
3. There is no difference/ difference in the severity of symptoms of HWA after 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 remain on their normal diet,
* Visit the clinic once every 1 month for 03 months for doses and assessment of symptoms and adverse events will be done.
* All 03 groups will be called after one month of the last dose and the blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and the severity of symptoms to assess the effectiveness of the intervention.
Phase:
NA
Details
Lead Sponsor:
Akram Medical Complex
Collaborators:
Scotmann Pharmaceuticals The Searle Company Limited Pakistan