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

  • STATUS
    Recruiting
  • End date
    Jan 10, 2024
  • participants needed
    150
  • sponsor
    PharmaLinea Ltd.
Updated on 15 May 2022

Summary

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.

Details
Condition Iron-deficiency, Iron Deficiency Anemia
Treatment Ferrous Sulfate Capsules, >Your< Iron Forte Capsules, >Your< Iron Forte Liquid, Blank Capsules, Blank Liquid
Clinical Study IdentifierNCT05185024
SponsorPharmaLinea Ltd.
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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