Clinical trial NCT05985070: Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Iron Deficiency
Iron Deficiency Anemia
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the serum iron concentration
timeFrame: 6 weeks
measure: Changes in the serum ferritin concentration
timeFrame: 6 weeks
measure: Change in blood Hemoglobin (Hb) levels
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
measure: Incidence of gastrointestinal side effects
timeFrame: 6 weeks
Locations:
city: Lahore
country: Pakistan
facility: Mayo Hospital
state: Punjab
city: Narowal
country: Pakistan
facility: DHQ Hospital Narowal
state: Punjab
city: Kotri
country: Pakistan
facility: Civil Hospital Kotri Distt Jamshoro
state: Sindh
Study officials:
References: