Iron-deficiencyIRON-RELOADNCT05185024
Daily Oral Iron Supplementation for Replenishment of Depleted Iron in Adults
A study testing Ferrous Sulfate Capsules, >Your< Iron Forte Capsules and >Your< Iron Forte Liquid in people with Iron-deficiency and Iron Deficiency Anemia, run by PharmaLinea Ltd. at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia
- What is being tested?
- Ferrous Sulfate Capsules, >Your< Iron Forte Capsules and >Your< Iron Forte Liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSlovenia
- Study dates
- 19 Jan 2022to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Iron-deficiency, Iron Deficiency Anemia
- Being tested
- Ferrous Sulfate Capsules, >Your< Iron Forte Capsules, >Your< Iron Forte Liquid, Blank Capsules, Blank Liquid
- Keywords
- iron deficiency, iron supplementation, dietary supplement, >Your< Iron
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous Sulfate CapsulesDietary supplement
Once daily dose of one Ferrous Sulfate Capsule for 12 weeks in total.
>Your< Iron Forte CapsulesDietary supplement
Once daily dose of one >Your< Iron Forte Capsule for 12 weeks in total.
>Your< Iron Forte LiquidDietary supplement
Once daily dose of 5 ml of >Your< Iron Forte Liquid for 12 weeks in total.
Blank CapsulesOther
Once daily dose of one Blank Capsule (excipients only) for 12 weeks in total.
Blank LiquidOther
Once daily dose of 5 ml of Blank Liquid (excipients only) for 12 weeks in total.
| Study group | Role | What they receive |
|---|---|---|
| Ferrous Sulfate Capsules | Experimental | 30 mg of elemental iron and 60 mg of vitamin C per capsule. Receives: 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. Receives: 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). Receives: Dietary Supplement: >Your< Iron Forte Liquid; Other: Blank Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin level from baseline to week 12.
Measurement in a venous blood sample.
Measured: 12 weeks
Secondary outcomes (15)
Change in hemoglobin from baseline at week 4.
Measurement in a venous blood sample.
Measured: 4 weeks
Change in hematocrit from baseline at week 4.
Measurement in a venous blood sample.
Measured: 4 weeks
Change in hematocrit from baseline at week 12.
Measurement in a venous blood sample.
Measured: 12 weeks
Change in mean corpuscular volume from baseline at week 4.
Measurement in a venous blood sample.
Measured: 4 weeks
Change in mean corpuscular volume from baseline at week 12.
Measurement in a venous blood sample.
Measured: 12 weeks
Change in mean corpuscular hemoglobin from baseline at week 4.
Measurement in a venous blood sample.
Measured: 4 weeks
Change in mean corpuscular hemoglobin from baseline at week 12.
Measurement in a venous blood sample.
Measured: 12 weeks
Change in mean corpuscular hemoglobin concentration from baseline at week 4.
Measurement in a venous blood sample.
Measured: 4 weeks
Change in mean corpuscular hemoglobin concentration from baseline at week 12.
Measurement in a venous blood sample.
Measured: 12 weeks
Change in serum ferritin level from baseline at week 4.
Measurement in a venous blood sample.
Measured: 4 weeks
Change in serum ferritin level from baseline at week 12.
Measurement in a venous blood sample.
Measured: 12 weeks
Change in transferrin saturation from baseline at week 4.
Measurement in a venous blood sample.
Measured: 4 weeks
Change in transferrin saturation from baseline at week 12.
Measurement in a venous blood sample.
Measured: 12 weeks
Collection and assessment of adverse events.
Collection and assessment of adverse events.
Measured: 4 weeks
Collection and assessment of adverse events.
Collection and assessment of adverse events.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start19 Jan 2022
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaLinea Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrej Kravos, MD, PhD, Principal investigator, Private Family Medicine Practice Andrej Kravos, MD, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185024
- Sponsor's protocol ID
- PhL-2021-IRON-RELOAD
- Acronym
- IRON-RELOAD
- Status last verified
- Mar 2024
- First submitted
- 20 Dec 2021
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05185024
- Acronym / sponsor ID
- IRON-RELOAD / PhL-2021-IRON-RELOAD
- Conditions
- Iron-deficiency, Iron Deficiency Anemia
- Keywords
- iron deficiency, iron supplementation, dietary supplement, >Your< Iron
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- PharmaLinea Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ferrous Sulfate Capsules | Experimental | Dietary Supplement: Ferrous Sulfate Capsules, Other: Blank Liquid30 mg of elemental iron and 60 mg of vitamin C per capsule. |
| >Your< Iron Forte Capsules | Experimental | Dietary Supplement: >Your< Iron Forte Capsules, Other: Blank Liquid30 mg of elemental iron and 60 mg of vitamin C per capsule. |
| >Your< Iron Forte Liquid | Experimental | Dietary Supplement: >Your< Iron Forte Liquid, Other: Blank Capsules35 mg of elemental iron, 0.7 mg vitamin B6 and 1.25 mcg vitamin B12 per one dosing (5 ml). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous Sulfate CapsulesOnce daily dose of one Ferrous Sulfate Capsule for 12 weeks in total. | Dietary supplement | Ferrous Sulfate Capsules |
| >Your< Iron Forte CapsulesOnce daily dose of one >Your< Iron Forte Capsule for 12 weeks in total. | Dietary supplement | >Your< Iron Forte Capsules |
| >Your< Iron Forte LiquidOnce daily dose of 5 ml of >Your< Iron Forte Liquid for 12 weeks in total. | Dietary supplement | >Your< Iron Forte Liquid |
| Blank CapsulesOnce daily dose of one Blank Capsule (excipients only) for 12 weeks in total. | Other | >Your< Iron Forte Liquid |
| Blank LiquidOnce daily dose of 5 ml of Blank Liquid (excipients only) for 12 weeks in total. | Other | >Your< Iron Forte Capsules, Ferrous Sulfate Capsules |
Primary outcome
Change in hemoglobin level from baseline to week 12.
Time frame: 12 weeks
Measurement in a venous blood sample.
15 secondary outcomes
Change in hemoglobin from baseline at week 4.
Time frame: 4 weeks
Change in hematocrit from baseline at week 4.
Time frame: 4 weeks
Change in hematocrit from baseline at week 12.
Time frame: 12 weeks
Change in mean corpuscular volume from baseline at week 4.
Time frame: 4 weeks
Change in mean corpuscular volume from baseline at week 12.
Time frame: 12 weeks
Change in mean corpuscular hemoglobin from baseline at week 4.
Time frame: 4 weeks
Change in mean corpuscular hemoglobin from baseline at week 12.
Time frame: 12 weeks
Change in mean corpuscular hemoglobin concentration from baseline at week 4.
Time frame: 4 weeks
Change in mean corpuscular hemoglobin concentration from baseline at week 12.
Time frame: 12 weeks
Change in serum ferritin level from baseline at week 4.
Time frame: 4 weeks
Change in serum ferritin level from baseline at week 12.
Time frame: 12 weeks
Change in transferrin saturation from baseline at week 4.
Time frame: 4 weeks
Change in transferrin saturation from baseline at week 12.
Time frame: 12 weeks
Collection and assessment of adverse events.
Time frame: 4 weeks
Collection and assessment of adverse events.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Kravos, MD, PhD principal investigator
Private Family Medicine Practice Andrej Kravos, MD, PhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous Sulfate Capsules, >Your< Iron Forte Capsules and >Your< Iron Forte Liquid in people with Iron-deficiency and Iron Deficiency Anemia, run by PharmaLinea Ltd. at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin level from baseline to week 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.