Iron DeficiencyNCT05985070
Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults
A study testing Oral Sucrosomial iron and Oral Ferric maltol in people with Iron Deficiency and Iron Deficiency Anemia, run by Liaquat University of Medical & Health Sciences at 3 sites in Pakistan.
Trial summary
Oral iron supplements are a cornerstone therapy for treating iron deficiency and iron deficiency anemia, aiming to replenish low iron levels in the body. These supplements typically contain various iron salts, such as ferrous sulfate, ferric maltol, ferrous gluconate, and ferric pyrophosphate. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Iron Deficiency Anemia
- What is being tested?
- Oral Sucrosomial iron and Oral Ferric maltol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 3 sitesPakistan
- Study dates
- 17 Jul 2023to 30 Jun 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Adults aged 18-65 years
- Iron deficiency, defined as low serum iron <50 µg/dL, ferritin <20 ng/mL, and TIBC >400 µg/dL.
- Able and willing to provide informed consent
- Willing to comply with oral supplementation and study follow-up
Who cannot join
- Severe anemia, defined as hemoglobin (Hb) <8 g/dL, requiring urgent intervention
- Known malabsorption syndromes (e.g., celiac disease, IBD)
- Active bleeding or blood transfusion within the past 3 months
- Pregnancy or lactation
- Use of iron supplements within the past 4 weeks
- Known allergy or intolerance to oral iron formulations
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Civil Hospital Kotri Distt Jamshoro
Kotri, Sindh, 76000
Mayo Hospital
Lahore, Punjab Province, 54000
DHQ Hospital Narowal
Narowal, Punjab Province, 51600
About this study
Official title: Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults: A Multicenter, Randomized, Double-blind, Parallel-group Pragmatic Clinical Trial
Oral iron supplements are a cornerstone therapy for treating iron deficiency and iron deficiency anemia, aiming to replenish low iron levels in the body. These supplements typically contain various iron salts, such as ferrous sulfate, ferric maltol, ferrous gluconate, and ferric pyrophosphate.
Advancements in carrier systems, such as microencapsulation or complexation can enhance the absorption and bioavailability of iron supplements. By improving absorption, these carrier systems may mitigate gastrointestinal side effects and increase the efficacy of iron therapy.
Read the detailed description
This multicenter, randomized, double-blind parallel-group, clinical trial study aims to conduct a comparative analysis of the effectiveness of oral ferric maltose, vs Sucrosomial iron. The study seeks to evaluate their efficacy in treating iron deficiency or iron deficiency anemia, two prevalent conditions associated with low iron levels in the body. This research aims to provide valuable insights into potential difference in these two iron supplement formulations, both in terms of relative effectiveness and potential GI side effects. This comparative analysis may guide healthcare providers in selecting the most suitable oral iron supplement based on individual patient characteristics, ultimately optimizing treatment outcomes and improving patient care.
- Conditions
- Iron Deficiency, Iron Deficiency Anemia
- Being tested
- Oral Sucrosomial iron, Oral Ferric maltol
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Sucrosomial ironDietary supplement
30 mg capsule
Oral Ferric maltolDietary supplement
30 mg capsule
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm 1 | Experimental | Subjects in this arm will receive an oral Sucrosomial 30mg elemental iron supplement, twice daily, for 6 weeks. Receives: Dietary Supplement: Oral Sucrosomial iron |
| Intervention Arm 2 | Active comparator | Subjects in this arm will receive an oral Ferric maltol 30mg elemental iron supplement, twice daily, for 6 weeks. Receives: Dietary Supplement: Oral Ferric maltol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the serum iron concentration
Increase in the circulatory iron levels
Measured: 6 weeks
Changes in the serum ferritin concentration
Increase in the circulatory ferritin levels
Measured: 6 weeks
Change in blood Hemoglobin (Hb) levels
Increase in the blood (Hb) levels
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start17 Jul 2023
- Primary completion15 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nazia Mumtaz Memon, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985070
- Sponsor's protocol ID
- LUMHS/REC/-86
- Status last verified
- Apr 2024
- First submitted
- 2 Aug 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults: A Multicenter, Randomized, Double-blind, Parallel-group Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT05985070
- Acronym / sponsor ID
- LUMHS/REC/-86
- Conditions
- Iron Deficiency, Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 14 Aug 2023 (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.
Oral iron supplements are a cornerstone therapy for treating iron deficiency and iron deficiency anemia, aiming to replenish low iron levels in the body. These supplements typically contain various iron salts, such as ferrous sulfate, ferric maltol, ferrous gluconate, and ferric pyrophosphate.
Advancements in carrier systems, such as microencapsulation or complexation can enhance the absorption and bioavailability of iron supplements. By improving absorption, these carrier systems may mitigate gastrointestinal side effects and increase the efficacy of iron therapy.
Detailed description
This multicenter, randomized, double-blind parallel-group, clinical trial study aims to conduct a comparative analysis of the effectiveness of oral ferric maltose, vs Sucrosomial iron. The study seeks to evaluate their efficacy in treating iron deficiency or iron deficiency anemia, two prevalent conditions associated with low iron levels in the body. This research aims to provide valuable insights into potential difference in these two iron supplement formulations, both in terms of relative effectiveness and potential GI side effects. This comparative analysis may guide healthcare providers in selecting the most suitable oral iron supplement based on individual patient characteristics, ultimately optimizing treatment outcomes and improving patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm 1 | Experimental | Dietary Supplement: Oral Sucrosomial ironSubjects in this arm will receive an oral Sucrosomial 30mg elemental iron supplement, twice daily, for 6 weeks. |
| Intervention Arm 2 | Active comparator | Dietary Supplement: Oral Ferric maltolSubjects in this arm will receive an oral Ferric maltol 30mg elemental iron supplement, twice daily, for 6 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Adults aged 18-65 years
- Iron deficiency, defined as low serum iron <50 µg/dL, ferritin <20 ng/mL, and TIBC >400 µg/dL.
- Able and willing to provide informed consent
- Willing to comply with oral supplementation and study follow-up
Key exclusion criteria (6 listed)
- Severe anemia, defined as hemoglobin (Hb) <8 g/dL, requiring urgent intervention
- Known malabsorption syndromes (e.g., celiac disease, IBD)
- Active bleeding or blood transfusion within the past 3 months
- Pregnancy or lactation
- Use of iron supplements within the past 4 weeks
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 |
|---|---|---|
| Oral Sucrosomial iron30 mg capsule | Dietary supplement | Intervention Arm 1 |
| Oral Ferric maltol30 mg capsule | Dietary supplement | Intervention Arm 2 |
Primary outcome
Changes in the serum iron concentration
Time frame: 6 weeks
Increase in the circulatory iron levels
Changes in the serum ferritin concentration
Time frame: 6 weeks
Increase in the circulatory ferritin levels
Change in blood Hemoglobin (Hb) levels
Time frame: 6 weeks
Increase in the blood (Hb) levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Sucrosomial iron and Oral Ferric maltol in people with Iron Deficiency and Iron Deficiency Anemia, run by Liaquat University of Medical & Health Sciences at 3 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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?
Changes in the serum iron concentration (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2025.