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

NCT05985070 | Active Not Recruiting DMC

• 1 other identifier: LUMHS/REC/-86
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

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.

Conditions

Iron Deficiency; Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (3)

• Changes in the serum iron concentration

  Increase in the circulatory iron levels

  6 weeks

• Changes in the serum ferritin concentration

  Increase in the circulatory ferritin levels

  6 weeks

• Change in blood Hemoglobin (Hb) levels

  Increase in the blood (Hb) levels

  6 weeks

Other Outcomes (1)

• Incidence of gastrointestinal side effects

  6 weeks

Study Arms (2)

Intervention Arm 1

EXPERIMENTAL

Subjects in this arm will receive an oral Sucrosomial 30mg elemental iron supplement, twice daily, for 6 weeks.

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.

Dietary Supplement: Oral Ferric maltol

Interventions

Oral Sucrosomial iron DIETARY_SUPPLEMENT

30 mg capsule

Intervention Arm 1

Oral Ferric maltol DIETARY_SUPPLEMENT

30 mg capsule

Intervention Arm 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead

Study Sites (3)

Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

DHQ Hospital Narowal

Narowal, Punjab Province, 51600, Pakistan

Location

Civil Hospital Kotri Distt Jamshoro

Kotri, Sindh, 76000, Pakistan

Location

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency

Interventions

sucrosomial iron; ferric maltol

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Pathology

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: July 17, 2023
• Primary Completion: May 15, 2025
• Study Completion: June 30, 2025
• Last Updated: April 16, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (3)