Daily Oral Iron Supplementation for Replenishment of Depleted Iron in Adults (IRON-RELOAD)

A Study of Efficacy and Safety of Three Different Oral Iron-Containing Dietary Supplements in Correction of Hematological Indices and Replenishment of Depleted Iron Stores in Iron Deficient Adults With or Without Mild Microcytic Anemia

The study is designed as a parallel, randomized, double blind, three-arm single-center study exploring the efficacy and safety of 12-week once daily oral dosing of iron for correction of overall iron status in 150 otherwise healthy iron-deficient adults presenting with or without mild microcytic anemia. Three iron-containing preparations in the form of either Ferrous Sulfate Capsules, >Your< Iron Forte Capsules, or >Your< Iron Forte Liquid will be tested. Potential study participants will be recruited from the general population of 18-50 year old adults. Participant eligibility will be determined by screening for hemoglobin and ferritin (in combination with C-reactive protein) levels in a sample of venous blood. Eligible individuals will be invited to participate in the study. Enrolled participants will be randomized into one of three intervention groups in a 1:1:1 ratio, receiving either Ferrous Sulfate Capsules, >Your< Iron Forte Capsules, or >Your< Iron Forte Liquid. Efficacy and safety of the assigned interventions will be evaluated through analyses of relevant hematological (hemoglobin, red blood cell indices) and biochemical (ferritin, transferrin saturation) iron-related parameters and reported adverse events after the first 4 and after a total of 12 weeks of intervention.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency; Iron Deficiency Anemia
• Intervention / Treatment: Dietary supplement: Ferrous Sulfate Capsules; Other: Blank Liquid; Dietary supplement: >Your< Iron Forte Capsules; Dietary supplement: >Your< Iron Forte Liquid; Other: Blank Capsules

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Diagnostic Laboratory Medicare Plus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Personally signed and dated Informed Consent Form.
• Male or female, aged 18-50 years (inclusive) at the time of signing the Informed Consent Form.
• Iron deficiency as defined by a hemoglobin value 100-130 g/L (females) and 110-140 g/L (males) and a serum ferritin level <30 µg/L (with C-reactive protein level <10 mg/L).
• Generally healthy individual with no known significant health problems as judged by the Investigator (based on the screening questionnaire responses, medical history, the results of clinical laboratory tests performed at screening, and the results of examination of vital signs).
• Body mass index ≤27 kg/m2.
• Ability to understand and willingness to comply with all protocol required visits, assessments, and interventions.

Exclusion Criteria:

• Occult gastrointestinal bleeding (as determined by the fecal occult blood test).
• Pronounced symptoms accompanying anemia (i. e., pronounced fatigue, dizziness, shortness of breath).
• Hemochromatosis or other iron-loading disorders.
• Known hemoglobinopathy (e. g., thalassemia).
• Any active or unstable concurrent medical condition (e. g., cancer, renal dysfunction, liver dysfunction).
• Presence of an inflammatory and/or autoimmune disorder (e. g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, celiac disease).
• Partial or total gastrectomy or any other surgical procedure bypassing the duodenum.
• Known HIV, HBV, or HCV infection.
• Any active chronic or acute infectious disease requiring antibiotic treatment.
• Taking regular medication that could affect iron absorption (e. g., antacids, proton pump inhibitors, histamine H2 blockers).
• Use of any iron-containing medications or supplements within 30 days prior to screening and at any time throughout the duration of the study.
• Received blood transfusion within 12 weeks prior to screening or planned blood transfusion during the study period.
• Receipt of i. m. or i. v. injection of depot iron preparation within 30 days prior to screening or at any time during the study.
• Receipt of erythropoiesis stimulating agents within 30 days prior to screening or at any time during the study.
• Blood donation within the previous 30 days or planned blood donation during the study period.
• Scheduled or expected hospitalization and/or surgery during the course of the study.
• Intake of concurrent medications that could interfere with physical or mental performance (e. g., antihistamines etc.).
• For women of childbearing potential: planning of pregnancy, current pregnancy, or lactation.
• Known allergies or severe adverse reactions to previous oral iron therapy or known hypersensitivity to any component of investigational products.
• Current participation in any other interventional clinical study or participation within 30 days prior to screening.
• Any other unspecified reason (laboratory abnormality, medical condition, or psychiatric or psychological disorder) which, in the opinion of the Investigator, makes the subject unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ferrous Sulfate Capsules; 30 mg of elemental iron and 60 mg of vitamin C per capsule.	Dietary supplement: Ferrous Sulfate Capsules; Once daily dose of one Ferrous Sulfate Capsule for 12 weeks in total.; Other: Blank Liquid; Once daily dose of 5 ml of Blank Liquid (excipients only) for 12 weeks in total.
Experimental: >Your< Iron Forte Capsules; 30 mg of elemental iron and 60 mg of vitamin C per capsule.	Other: Blank Liquid; Once daily dose of 5 ml of Blank Liquid (excipients only) for 12 weeks in total.; Dietary supplement: >Your< Iron Forte Capsules; Once daily dose of one >Your< Iron Forte Capsule for 12 weeks in total.
Experimental: >Your< Iron Forte Liquid; 35 mg of elemental iron, 0.7 mg vitamin B6 and 1.25 mcg vitamin B12 per one dosing (5 ml).	Dietary supplement: >Your< Iron Forte Liquid; Once daily dose of 5 ml of >Your< Iron Forte Liquid for 12 weeks in total.; Other: Blank Capsules; Once daily dose of one Blank Capsule (excipients only) for 12 weeks in total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin level from baseline to week 12.	Measurement in a venous blood sample.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin from baseline at week 4.	Measurement in a venous blood sample.	4 weeks
Change in hematocrit from baseline at week 4.	Measurement in a venous blood sample.	4 weeks
Change in hematocrit from baseline at week 12.	Measurement in a venous blood sample.	12 weeks
Change in mean corpuscular volume from baseline at week 4.	Measurement in a venous blood sample.	4 weeks
Change in mean corpuscular volume from baseline at week 12.	Measurement in a venous blood sample.	12 weeks
Change in mean corpuscular hemoglobin from baseline at week 4.	Measurement in a venous blood sample.	4 weeks
Change in mean corpuscular hemoglobin from baseline at week 12.	Measurement in a venous blood sample.	12 weeks
Change in mean corpuscular hemoglobin concentration from baseline at week 4.	Measurement in a venous blood sample.	4 weeks
Change in mean corpuscular hemoglobin concentration from baseline at week 12.	Measurement in a venous blood sample.	12 weeks
Change in serum ferritin level from baseline at week 4.	Measurement in a venous blood sample.	4 weeks
Change in serum ferritin level from baseline at week 12.	Measurement in a venous blood sample.	12 weeks
Change in transferrin saturation from baseline at week 4.	Measurement in a venous blood sample.	4 weeks
Change in transferrin saturation from baseline at week 12.	Measurement in a venous blood sample.	12 weeks
Collection and assessment of adverse events.	Collection and assessment of adverse events.	4 weeks
Collection and assessment of adverse events.	Collection and assessment of adverse events.	12 weeks

Collaborators and Investigators

• Sponsor: PharmaLinea Ltd.
• Investigators: Principal Investigator: Andrej Kravos, MD, PhD, Private Family Medicine Practice Andrej Kravos, MD, PhD

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: dietary supplement; iron deficiency; iron supplementation; >Your< Iron
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Iron Deficiencies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: PhL-2021-IRON-RELOAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No