Daily Oral Iron Supplementation for Replenishment of Depleted Iron in Adults

NCT05185024 | Completed

• 1 other identifier: PhL-2021-IRON-RELOAD
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron-deficiency; Iron Deficiency Anemia

Keywords

iron deficiency; iron supplementation; dietary supplement; >Your< Iron

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin level from baseline to week 12.

  Measurement in a venous blood sample.

  12 weeks

Secondary Outcomes (15)

• Change in hemoglobin from baseline at week 4.

  4 weeks

• Change in hematocrit from baseline at week 4.

  4 weeks

• Change in hematocrit from baseline at week 12.

  12 weeks

• Change in mean corpuscular volume from baseline at week 4.

  4 weeks

• Change in mean corpuscular volume from baseline at week 12.

  12 weeks

Study Arms (3)

Ferrous Sulfate Capsules

EXPERIMENTAL

30 mg of elemental iron and 60 mg of vitamin C per capsule.

Dietary Supplement: Ferrous Sulfate Capsules; Other: Blank Liquid

>Your< Iron Forte Capsules

EXPERIMENTAL

30 mg of elemental iron and 60 mg of vitamin C per capsule.

Dietary Supplement: >Your< Iron Forte Capsules; Other: Blank Liquid

>Your< Iron Forte Liquid

EXPERIMENTAL

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; Other: Blank Capsules

Interventions

Ferrous Sulfate Capsules DIETARY_SUPPLEMENT

Once daily dose of one Ferrous Sulfate Capsule for 12 weeks in total.

Ferrous Sulfate Capsules

>Your< Iron Forte Capsules DIETARY_SUPPLEMENT

Once daily dose of one \>Your\< Iron Forte Capsule for 12 weeks in total.

>Your< Iron Forte Capsules

>Your< Iron Forte Liquid DIETARY_SUPPLEMENT

Once daily dose of 5 ml of \>Your\< Iron Forte Liquid for 12 weeks in total.

>Your< Iron Forte Liquid

Blank Capsules OTHER

Once daily dose of one Blank Capsule (excipients only) for 12 weeks in total.

>Your< Iron Forte Liquid

Blank Liquid OTHER

Once daily dose of 5 ml of Blank Liquid (excipients only) for 12 weeks in total.

>Your< Iron Forte Capsules; Ferrous Sulfate Capsules

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmaLinea Ltd.: lead

Study Sites (1)

Diagnostic Laboratory Medicare Plus

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrej Kravos, MD, PhD

  Private Family Medicine Practice Andrej Kravos, MD, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 11, 2022
• Study Start: January 19, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)