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Completed
NCT06437080
Hypoferritinemia Without Anemia Among Reproductive Age Females
Conditions: Hypoferritenemia Without Anemia (HWA), Iron Deficiency Without Anemia)
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 300
Sponsor: Akram Medical Complex
Location: Fatima Memorial Hospital Lahore Punjab Province
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.
Eligibility Criteria
Inclusion Criteria:
* Reproductive age females: 18 to 45 years
* Clinical symptoms of iron deficiency which are fatigue/ tiredness, poor work productivity, poor attention and memory loss, sore tongue, poor condition of skin, nails or hair, including hair loss, delayed skin wound healing, palpitation and restless leg syndrome
* Normal CBC: hemoglobin level12mg/dl and above
* Serum ferritin levels: below 30 ng/ml
* Normal thyroid levels
* Normal blood sugar levels
* Willing and able to sign informed consent
Exclusion Criteria:
* Males
* Post-menopausal
* Premature menopause
* Anemic Females: hemoglobin levels i.e. less than 12 g/dl
* Serum ferritin level above 30 ng/ml.
* Disturbed thyroid levels
* Disturbed blood sugar levels
* Pregnant
* Lactating
* Blood donors
* Co-morbidities i.e., celiac disease, hemorrhoids, malignancies, hematuria, ulcers, heart failure, renal failure, chronic gastric symptoms/ gastric ulcers, chronic liver disease, disturbed thyroid levels and diabetes
* Any medication or supplement which may impact iron metabolism.
* History of iron or multivitamins supplementation in the last 3 months
Source: ClinicalTrials.gov (NCT06437080). StuddyBuddy aggregates publicly available trial information.