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This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.
During the enrollment (baseline) visit, subjects will undergo a blood draw to assess hemoglobin, ferritin and soluble transferrin receptor (sTfR) levels to confirm current depleted iron stores and will then be randomly allocated into one of the two study arms. All ferrous sulfate (oral tablets) will be provided to patients by the investigators. All subjects will be instructed to take oral iron on an empty stomach or 1 hour after meals for better absorption, preferably with a vitamin C rich product such as orange juice. To minimize variability introduced by other potential iron sources, prenatal vitamins that have the same amount and form of iron will be provided to both study groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1) Daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill | Experimental | daily (Group 1) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill |
|
| 2) Alternate daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill | Experimental | alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill | Drug | ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| reversal of iron deficient anemia | hemoglobin > 10.5 g/dL | 8 weeks after the baseline visit ± 7 days |
| reversal of iron deficient anemia | ferritin > 15 mcg/L | 8 weeks after the baseline visit ± 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| soluble transferrin receptor (sTfR) levels within normal range | 1.8-4.6 mg/L | 8 weeks after the baseline visit ± 7 days |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen A Groesch, MS | Contact | 217-545-6671 | kgroesch@siumed.edu | |
| Teresa S Wilson, BA | Contact | 217-545-6711 | twilson2@siumed.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yahia Zeino, MD | Southern Illinois University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Illinois University School of Medicine | Recruiting | Springfield | Illinois | 62702 | United States |
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Randomized 1:1 for daily iron (ferrous sulfate) supplementation vs. every other day iron (ferrous sulfate) supplementation
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|
| alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill | Drug | ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill every other day |
|
|
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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