Hypoferritenemia Without Anemia (HWA)NCT06437080
Hypoferritinemia Without Anemia Among Reproductive Age Females
A study testing Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg and Ferric Carboxymaltose in people with Hypoferritenemia Without Anemia (HWA) and Iron Deficiency Without Anemia), run by Akram Medical Complex at 4 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoferritenemia Without Anemia (HWA), Iron Deficiency Without Anemia)
- What is being tested?
- Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg and Ferric Carboxymaltose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesPakistan
- Study dates
- 10 Oct 2022to 16 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Pakistan4 sites
Fatima Memorial Hospital
Lahore, Punjab Province, 54782
General Hospital Lahore
Lahore, Punjab Province, 54782
Gulab Devi Hospital
Lahore, Punjab Province, 54782
Sir Gangaram Hospital
Lahore, Punjab Province, 54782
About this study
Official title: Hypoferritinemia Without Anemia Among Reproductive Age Females: Frequency, Determinants and Treatment Outcomes
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.
Read the detailed description
At present the commonly identified presentation is Iron Deficiency Anemia which currently affects more than 1 billion people while Hypoferritenemia without Anemia (HWA) is at least twice as common. HWA is poorly recognized by clinicians despite its high prevalence, probably because of suboptimal screening recommendations.
HWA: Patients having normal Hemoglobin of ≥12 g/dl and having below normal range ferritin level < 30ng/ml and patients suffering from any of the following symptoms of
- Fatigue/ tiredness
- Poor work productivity
- Poor attention
- Poor memory
- Sore tongue
- Poor condition of skin, nails or hair, including hair loss.
- Delayed skin wound healing
- Palpitation
- Restless Leg Syndrome
As the symptoms and signs of the HWA are nonspecific which may happen in other systemic diseases or psychiatric disorders so patients with HWA are either recommended no tests or later on end up with expensive tests for heart failure and renal failure on the other end which can be the result of chronic iron deficiency. Clinicians usually advise iron studies when there is documented anemia which results in underdiagnoses of HWA.
To the best of researcher's knowledge, no study related to HWA has been conducted in Pakistan; therefore, the prevalence of Iron Deficiency Anemia (IDA) in Pakistan has been added in the present literature review. Results show that a total of 45% of population is suffering from IDA in Pakistan.
The rationale of this study is to highlight the struggling issue of HWA which is battling to be recognized as one of the factors contributing to the symptoms indicated above, as was previously stated. This study is important to be conducted as it will not only pave ways to recognize the category of HWA but will also help patients to receive targeted treatment and saving them from the risk of drug abuse and over-medication. As per the researcher's knowledge, there is a scarcity of data on Pakistan's population as no study exists on HWA in Pakistan.
Above literature review clearly reflects that there is a wide gap regarding some aspects of HWA. First, it is an underdiagnosed entity as it has nonspecific symptoms which can be found in other diseases. Although there are estimates of disease burden, but exact value is not known especially in developing countries. Secondly, there is a lot of data regarding causes of iron deficiency but paucity exists regarding determinants/causes of HWA. Thirdly, there is contrary data regarding management, few investigators believe that oral iron therapy shall be the first line therapy while other believes that intravenous (IV) therapy shall be given first to reduce symptoms.
OBJECTIVES
- To determine the frequency of HWA among women of reproductive age
- To compare the treatment outcomes of oral iron supplementation (Group 1) versus Intravenous (IV) iron supplementation (Group 2) versus normal diet (Group 3) on the serum ferritin level after four months of start of intervention
- To determine the outcomes in the severity of symptoms of HWA after four months of start of intervention
Data Analysis Plan
The data analysis for this study is conducted using SPSS version 27 to evaluate the effects of oral iron supplementation, intravenous iron supplementation, and no treatment on serum ferritin levels and symptom severity after four months of intervention. To ensure the validity of statistical tests, the normality of the data is first assessed using the Shapiro-Wilk test, complemented by histograms and QQ plots for visual confirmation. The results from the Shapiro-Wilk test indicate that the data follows a normal distribution, validating the use of parametric tests for subsequent analyses.
For the primary outcome of serum ferritin levels, a paired sample t-test is applied to compare the pre- and post-treatment levels within each group. This test reveals the effectiveness of the interventions in increasing ferritin levels over time, highlighting significant changes, especially in the intravenous iron supplementation group. To assess the change in symptom severity, ANOVA is used to compare differences across the three groups, showing the relative impact of each treatment, for all tests, a significance level of p < 0.05 is considered. Missing data are handled using sensitivity analysis to ensure that any potential biases do not affect the results, allowing for a more robust and reliable interpretation of the treatment outcomes. The overall analysis provides strong evidence of the most effective intervention for improving serum ferritin levels and alleviating the symptoms of hypoferritinemia without anemia
- Being tested
- Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg, Ferric Carboxymaltose
- Keywords
- Hypoferritenemia without Anemia (HWA), Reproductive age females, Symptoms of HWA, Determinants of HWA, Low serum ferritin levels, Iron deficiency, Cross-sectional study (Phase 1), Randomized controlled trial (Phase 2), Transferrin saturation (TSAT), Intervention
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mgDrug
Also called Fersip
01 tablet daily for 03 months, This is assigned to Group A.
Ferric CarboxymaltoseDrug
Also called Ferinject
03 doses (50 mg iron/mL) per month for 03 months. This is assigned to Group B.
| Study group | Role | What they receive |
|---|---|---|
| Oral iron supplement | Active comparator | 100 participants of Group A will get oral iron supplementation (Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron), 100 mg for 03 months. Participants will consume 01 tablet per day for 03 months.
After completion of the treatment period blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention. Receives: Drug: Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg |
| Intravenous (IV) iron supplementation | Active comparator | 100 participants of Group B will get IV iron supplementation (Ferric Carboxymaltose) for 03 months (01 dose per month for 03 months).
After completion of the treatment period blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention. Receives: Drug: Ferric Carboxymaltose |
| Normal diet | No intervention | 100 participants will remain on their normal diet for 03 months. After 03 months blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ferritin levels
Serum ferritin levels before and after intervention
Measured: Baseline, week 16
Changes in symptom severity
Symptom severity score before and after intervention: This questionnaire contains eight questions with multiple-choice responses, with a score ranging from 0 point (not at all), 1 point (mild symptoms/ rarely), 2 points (moderate/ sometimes) and 3 points (severe/ frequently). The total symptom severity score will be calculated as the mean of the scores for the eight individual items and will be recorded at week 2 and week 16
Measured: Week 2, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start10 Oct 2022
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypoferritenemia Without Anemia (HWA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After randomization, 100 patients will be allocated to each of the three study groups, (total participants selected 300) 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. All 03 groups will be called and their blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention.
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akram Medical Complex
- Sponsor type
- University, hospital or other
- Collaborators
- Scotmann Pharmaceuticals, The Searle Company Limited Pakistan
- Responsible party
- Principal investigator, Shehla Javed Akram, University of Lahore
- Investigators
- Dr. Abdul Majeed Akhtar, MBBS, PhD, Study chair, The univeristy of LahoreDr. Rubeena Zakir, MBBS, PhD, Study director, University of Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437080
- Sponsor's protocol ID
- 70122031
- Status last verified
- May 2026
- First submitted
- 21 May 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abuaisha M, Itani H, El Masri R, Antoun J. Prevalence of Iron Deficiency (ID) without anemia in the general population presenting to primary care clinics: a cross-sectional study. Postgrad Med. 2020 Apr;132(3):282-287. doi: 10.1080/00325481.2020.1715701. Epub 2020 Jan 22.
PubMed 31933400Adams J, White M. Characterisation of UK diets according to degree of food processing and associations with socio-demographics and obesity: cross-sectional analysis of UK National Diet and Nutrition Survey (2008-12). Int J Behav Nutr Phys Act. 2015 Dec 18;12:160. doi: 10.1186/s12966-015-0317-y.
PubMed 26684833Al-Jafar HA. HWA: Hypoferritinemia without anemia a hidden hematology disorder. J Family Med Prim Care. 2017 Jan-Mar;6(1):69-72. doi: 10.4103/2249-4863.214986.
PubMed 29026752
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoferritinemia Without Anemia Among Reproductive Age Females: Frequency, Determinants and Treatment Outcomes
- ClinicalTrials.gov ID
- NCT06437080
- Acronym / sponsor ID
- 70122031
- Keywords
- Hypoferritenemia without Anemia (HWA), Reproductive age females, Symptoms of HWA, Determinants of HWA, Low serum ferritin levels, Iron deficiency, Cross-sectional study (Phase 1), Randomized controlled trial (Phase 2), Transferrin saturation (TSAT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Akram Medical ComplexUniversity, hospital or other
- Collaborators
- Scotmann Pharmaceuticals, The Searle Company Limited Pakistan
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At present the commonly identified presentation is Iron Deficiency Anemia which currently affects more than 1 billion people while Hypoferritenemia without Anemia (HWA) is at least twice as common. HWA is poorly recognized by clinicians despite its high prevalence, probably because of suboptimal screening recommendations.
HWA: Patients having normal Hemoglobin of ≥12 g/dl and having below normal range ferritin level < 30ng/ml and patients suffering from any of the following symptoms of
- Fatigue/ tiredness
- Poor work productivity
- Poor attention
- Poor memory
- Sore tongue
- Poor condition of skin, nails or hair, including hair loss.
- Delayed skin wound healing
- Palpitation
- Restless Leg Syndrome
As the symptoms and signs of the HWA are nonspecific which may happen in other systemic diseases or psychiatric disorders so patients with HWA are either recommended no tests or later on end up with expensive tests for heart failure and renal failure on the other end which can be the result of chronic iron deficiency. Clinicians usually advise iron studies when there is documented anemia which results in underdiagnoses of HWA.
To the best of researcher's knowledge, no study related to HWA has been conducted in Pakistan; therefore, the prevalence of Iron Deficiency Anemia (IDA) in Pakistan has been added in the present literature review. Results show that a total of 45% of population is suffering from IDA in Pakistan.
The rationale of this study is to highlight the struggling issue of HWA which is battling to be recognized as one of the factors contributing to the symptoms indicated above, as was previously stated. This study is important to be conducted as it will not only pave ways to recognize the category of HWA but will also help patients to receive targeted treatment and saving them from the risk of drug abuse and over-medication. As per the researcher's knowledge, there is a scarcity of data on Pakistan's population as no study exists on HWA in Pakistan.
Above literature review clearly reflects that there is a wide gap regarding some aspects of HWA. First, it is an underdiagnosed entity as it has nonspecific symptoms which can be found in other diseases. Although there are estimates of disease burden, but exact value is not known especially in developing countries. Secondly, there is a lot of data regarding causes of iron deficiency but paucity exists regarding determinants/causes of HWA. Thirdly, there is contrary data regarding management, few investigators believe that oral iron therapy shall be the first line therapy while other believes that intravenous (IV) therapy shall be given first to reduce symptoms.
OBJECTIVES
- To determine the frequency of HWA among women of reproductive age
- To compare the treatment outcomes of oral iron supplementation (Group 1) versus Intravenous (IV) iron supplementation (Group 2) versus normal diet (Group 3) on the serum ferritin level after four months of start of intervention
- To determine the outcomes in the severity of symptoms of HWA after four months of start of intervention
Data Analysis Plan
The data analysis for this study is conducted using SPSS version 27 to evaluate the effects of oral iron supplementation, intravenous iron supplementation, and no treatment on serum ferritin levels and symptom severity after four months of intervention. To ensure the validity of statistical tests, the normality of the data is first assessed using the Shapiro-Wilk test, complemented by histograms and QQ plots for visual confirmation. The results from the Shapiro-Wilk test indicate that the data follows a normal distribution, validating the use of parametric tests for subsequent analyses.
For the primary outcome of serum ferritin levels, a paired sample t-test is applied to compare the pre- and post-treatment levels within each group. This test reveals the effectiveness of the interventions in increasing ferritin levels over time, highlighting significant changes, especially in the intravenous iron supplementation group. To assess the change in symptom severity, ANOVA is used to compare differences across the three groups, showing the relative impact of each treatment, for all tests, a significance level of p < 0.05 is considered. Missing data are handled using sensitivity analysis to ensure that any potential biases do not affect the results, allowing for a more robust and reliable interpretation of the treatment outcomes. The overall analysis provides strong evidence of the most effective intervention for improving serum ferritin levels and alleviating the symptoms of hypoferritinemia without anemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- After randomization, 100 patients will be allocated to each of the three study groups, (total participants selected 300) 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. All 03 groups will be called and their blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Oral iron supplement | Active comparator | Drug: Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg100 participants of Group A will get oral iron supplementation (Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron), 100 mg for 03 months. Participants will consume 01 tablet per day for 03 months. After completion of the treatment period blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention. |
| Intravenous (IV) iron supplementation | Active comparator | Drug: Ferric Carboxymaltose100 participants of Group B will get IV iron supplementation (Ferric Carboxymaltose) for 03 months (01 dose per month for 03 months). After completion of the treatment period blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention. |
| Normal diet | No intervention | –100 participants will remain on their normal diet for 03 months. After 03 months blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and severity of symptoms to assess the effectiveness of the intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- Males
- Post-menopausal
- Premature menopause
- Anemic Females: hemoglobin levels i.e. less than 12 g/dl
- Serum ferritin level above 30 ng/ml.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mgAlso: Fersip01 tablet daily for 03 months, This is assigned to Group A. | Drug | Oral iron supplement |
| Ferric CarboxymaltoseAlso: Ferinject03 doses (50 mg iron/mL) per month for 03 months. This is assigned to Group B. | Drug | Intravenous (IV) iron supplementation |
Primary outcome
Serum ferritin levels
Time frame: Baseline, week 16
Serum ferritin levels before and after intervention
Changes in symptom severity
Time frame: Week 2, Week 16
Symptom severity score before and after intervention: This questionnaire contains eight questions with multiple-choice responses, with a score ranging from 0 point (not at all), 1 point (mild symptoms/ rarely), 2 points (moderate/ sometimes) and 3 points (severe/ frequently). The total symptom severity score will be calculated as the mean of the scores for the eight individual items and will be recorded at week 2 and week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 31933400Abuaisha M, Itani H, El Masri R, Antoun J. Prevalence of Iron Deficiency (ID) without anemia in the general population presenting to primary care clinics: a cross-sectional study. Postgrad Med. 2020 Apr;132(3):282-287. doi: 10.1080/00325481.2020.1715701. Epub 2020 Jan 22.
- Background: PubMed 26684833Adams J, White M. Characterisation of UK diets according to degree of food processing and associations with socio-demographics and obesity: cross-sectional analysis of UK National Diet and Nutrition Survey (2008-12). Int J Behav Nutr Phys Act. 2015 Dec 18;12:160. doi: 10.1186/s12966-015-0317-y.
- Background: PubMed 29026752Al-Jafar HA. HWA: Hypoferritinemia without anemia a hidden hematology disorder. J Family Med Prim Care. 2017 Jan-Mar;6(1):69-72. doi: 10.4103/2249-4863.214986.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Abdul Majeed Akhtar, MBBS, PhD study chair
The univeristy of Lahore
Dr. Rubeena Zakir, MBBS, PhD study director
University of Punjab
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg and Ferric Carboxymaltose in people with Hypoferritenemia Without Anemia (HWA) and Iron Deficiency Without Anemia), run by Akram Medical Complex at 4 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum ferritin levels (time frame: Baseline, week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06437080, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.