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Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05985070
Enrollment
59
Registered
2023-08-14
Start date
2023-07-17
Completion date
2025-06-30
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency, Iron Deficiency Anemia

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTOral Sucrosomial iron

30 mg capsule

DIETARY_SUPPLEMENTOral Ferric maltol

30 mg capsule

Sponsors

Liaquat University of Medical & Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in the serum iron concentration6 weeksIncrease in the circulatory iron levels
Changes in the serum ferritin concentration6 weeksIncrease in the circulatory ferritin levels
Change in blood Hemoglobin (Hb) levels6 weeksIncrease in the blood (Hb) levels

Other

MeasureTime frameDescription
Incidence of gastrointestinal side effects6 weeksIncidence of treatment-emergent gastrointestinal side effects

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026