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| Name | Class |
|---|---|
| Sprim Advanced Life Sciences | OTHER |
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The purpose of this study is to compare the gastrointestinal (GI) tolerability of 5 different iron supplements (Ferrochel®, Sumalate®,ferrous fumarate, ferrous sulfate and ferric glycinate) at the same dose (90mg) and placebo.
Anemia, the most common disorder of blood, is characterized by a decrease in number of red blood cells (RBCs) or less than normal quantity of hemoglobin in blood.Hemoglobin is an oxygen-carrying protein inside RBCs that transports oxygen from the respiratory organs to the rest of body. Several vitamins, minerals and nutrients are required for the development and production of RBCs, such as vitamin B12, folic acid and iron. Iron is an essential component of hemoglobin. Iron deficiency accounts for half of the anemia cases worldwide, and iron deficiency anemia is the most common nutritional disorder in the world.Iron deficiency can be the result of inadequate intake in the diet, poor absorption, the extra needs during growth or pregnancy, and blood loss. Thus, children and women are at highest risk.
Full blood count and hemoglobin measurements are used to diagnose anemia, and measurement of serum ferritin level (cutoff of 12-15 mg/l) is considered as the best single and non-invasive test for the diagnosis of iron-deficiency. Treatment of anemia depends on the cause and the severity. Oral iron supplement is the simplest and most cost-effective option to treat anemia and replenish body storage.
The objective of this clinical trial is to compare the gastrointestinal (GI) tolerability of 5 different iron supplements (Ferrochel®, Sumalate®,ferrous fumarate, ferrous sulfate and ferric glycinate) at the same dose (90mg)and placebo. The primary objective is to compare the gastrointestinal tolerability of the above quoted products through:
The Secondary objective of the study is to assess the change from baseline of the parameters below:
This prospective clinical trial is a single-center, six-arms, randomized, double-blinded, parallel study. Subject will be screened according to inclusion exclusion criteria, and blood sample will be collected to ensure the hemoglobin and ferritin levels. Subject also will be asked to complete the Gastrointestinal Symptoms Questionnaire. The study product will be administered 30 days, orally once daily in the morning after breakfast. The study plan as follow:
Visit 1: Screening / Baseline (day -7)
Visit 2: Day 0
Visit 3: Day 15 Window period ± 2 days will be allowed for this visit
Visit 4: Day 30 Window period ± 2 days will be allowed for this visit
Visit 5: Day 37 Window period ± 2 days will be allowed for this visit
Adverse Event and Serious Adverse Event will be recorded since the subjects begin consuming the investigational product and throughout the study. SAE should be recorded in the SAE form and reported to Sponsor or CRA within 24 hours. All SAE will be reported to Ethic Committee and Regulatory Authority.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrochel® 90 mg | Active Comparator | Ferrochel® capsule 90 mg OD for 30 days |
|
| Sumalate® 90 mg | Active Comparator | Sumalate® capsule 90 mg OD for 30 days |
|
| Ferrous Fumarate 90 mg | Active Comparator | Ferrous Fumarate capsule 90 mg OD for 30 days |
|
| Ferrous Sulfate 90 mg | Active Comparator | Ferrous Sulfate capsule 90 mg OD for 30 days |
|
| Ferric glycinate 90 mg | Active Comparator | Ferric glycinate capsule 90 mg OD for 30 days |
|
| Placebo | Active Comparator | Placebo capsule OD for 30 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrochel® 90 mg | Dietary Supplement | Ferrochel® capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal questionnaire to measure the gastrointestinal tolerability | The gastrointestinal tolerability of the products will be assessed by self-assessment questionnaires and self-reported diaries at baseline (screening), day 0, day 15, day 30 of investigational product consumption, and 7 days after finished the investigational product. | change from baseline in Gastrointestinal questionnaire on 7 days after the last dose of 30 days investigational product consumption |
| Measure | Description | Time Frame |
|---|---|---|
| the laboratory result to measure the change from baseline | hemoglobin levels of each subject will be measured at baseline (screening), day 0, day 15 and day 30 of investigational product consumption | up to 30 days of investigational product consumption |
| the laboratory result to measure the change from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eka Windari Rusman | Contact | +62 21 83701201 | eka.windari@sprim.com | |
| Jennifer Hartle | Contact | 8017734631 | jhartle@albionminerals.com |
| Name | Affiliation | Role |
|---|---|---|
| Yahdiana Harahap, Professor | Laboratory Faculty of Pharmacy, Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory Faculty of Pharmacy, Universitas Indonesia | Recruiting | Depok | West Java | 16424 | Indonesia |
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| Sumalate® 90 mg | Dietary Supplement | Sumalate® capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days |
|
|
| Ferrous fumarate 90 mg | Dietary Supplement | Ferrous fumarate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days |
|
| Ferrous Sulfate 90 mg | Dietary Supplement | Ferrous Sulfate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days |
|
| Ferric Glycinate 90 mg | Dietary Supplement | Ferric Glycinate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days |
|
| Placebo | Dietary Supplement | Placebo capsule, administered orally once daily in the morning after breakfast, for 30 days |
|
Hematocrit levels of each subject will be measured at baseline (screening), day 0, day 15 and day 30 of investigational product consumption |
| up to 30 days of investigational product consumption |
| the laboratory result to measure the change from baseline | Ferritin levels of each subject will be measured at baseline (screening), day 0, day 15 and day 30 of investigational product consumption | up to 30 days of investigational product consumption |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C073588 | bis-glycino iron II |
| C510030 | ferrous bisglycinate |
| C031621 | ferrous fumarate |
| C020748 | ferrous sulfate |
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