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Hypoferritinemia Without Anemia Among Reproductive Age Females

NCT06437080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1331

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Hypoferritenemia Without Anemia (HWA)
  • Iron Deficiency Without Anemia)

Interventions

DRUG

Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg

01 tablet daily for 03 months, This is assigned to Group A.

DRUG

Ferric Carboxymaltose

03 doses (50 mg iron/mL) per month for 03 months. This is assigned to Group B.

Sponsors & Collaborators

  • Scotmann Pharmaceuticals

    collaborator INDUSTRY

  • The Searle Company Limited Pakistan

    collaborator INDUSTRY

  • Akram Medical Complex

    lead OTHER

Principal Investigators

  • Dr. Abdul Majeed Akhtar, MBBS, PhD · The univeristy of Lahore

  • Dr. Rubeena Zakir, MBBS, PhD · University of Punjab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06437080 on ClinicalTrials.gov