CompletedNot Applicable

Hypoferritinemia Without Anemia Among Reproductive Age Females

Pakistan1,331 participantsStarted 2022-10-10

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serum ferritin levels

Timeframe: Baseline, week 16

Changes in symptom severity

Timeframe: Week 2, Week 16

Socio demographic characteristics of participants

Timeframe: Week 1 (Baseline)

Trial details

NCT IDNCT06437080

SponsorAkram Medical Complex

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-16

View on ClinicalTrials.gov More Hypoferritenemia Without Anemia (HWA) trials