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Iron deficiency (ID) with or without anemia is a major public health problem worldwide, especially in women of reproductive age. Iron supplementation can be an effective strategy to prevent and treat ID and iron deficiency anemia (IDA). Recent studies suggests that giving oral iron every other day would be an optimized dosing regimen with maximized absorption and a lower incidence of gastrointestinal side effects compared to consecutive day dosing. Long-term trials in which participants and investigators are blinded to the dosing interval with iron status and gastrointestinal side effects as study outcomes are needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consecutive Day Dosing | Active Comparator | 100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months. |
|
| Alternate Day Dosing | Experimental | 100 mg iron as FeSO4 and matched placebo on alternating days for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consecutive Day Dosing | Dietary Supplement | 100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Ferritin (SF) | in consecutive day group | Day 93 |
| Serum Ferritin (SF) | in alternate day group | Day 186 |
| Event rate of GI side effects | in consecutive day group | Day 90 |
| Event rate of GI side effects | in alternate day group | Day 183 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin (Hb) | Day 0 | |
| Hemoglobin (Hb) | Day 46 | |
| Hemoglobin (Hb) |
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Inclusion Criteria:
Exclusion Criteria:
women
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Stoffel, Dr. | Human Nutrition Laboratory, ETH Zuerich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and Health | Zurich | 8092 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38021373 | Derived | von Siebenthal HK, Gessler S, Vallelian F, Steinwendner J, Kuenzi UM, Moretti D, Zimmermann MB, Stoffel NU. Alternate day versus consecutive day oral iron supplementation in iron-depleted women: a randomized double-blind placebo-controlled study. EClinicalMedicine. 2023 Nov 3;65:102286. doi: 10.1016/j.eclinm.2023.102286. eCollection 2023 Nov. |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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double-blinded randomized controlled study: participants and investigators are blinded
| Alternate Day Dosing | Dietary Supplement | 100 mg iron as FeSO4 and matched placebo on alternating days for 6 months. |
|
| Day 90 |
| Hemoglobin (Hb) | Day 139 |
| Hemoglobin (Hb) | Day 183 |
| Serum Ferritin (SF) | Day 0 |
| Serum Ferritin (SF) | Day 46 |
| Serum Ferritin (SF) | Day 93 |
| Serum Ferritin (SF) | Day 139 |
| Serum Ferritin (SF) | Day 186 |
| Serum Transferrin Receptor (sTfR) | Day 0 |
| Serum Transferrin Receptor (sTfR) | Day 46 |
| Serum Transferrin Receptor (sTfR) | Day 93 |
| Serum Transferrin Receptor (sTfR) | Day 139 |
| Serum Transferrin Receptor (sTfR) | Day 186 |
| Total iron binding capacity (TIBC) | Day 0 |
| Total iron binding capacity (TIBC) | Day 93 |
| Total iron binding capacity (TIBC) | Day 186 |
| Serum Iron (SFe) | Day 0 |
| Serum Iron (SFe) | Day 93 |
| Serum Iron (SFe) | Day 186 |
| C-Reactive Protein (CRP) | Day 0 |
| C-Reactive Protein (CRP) | Day 46 |
| C-Reactive Protein (CRP) | Day 93 |
| C-Reactive Protein (CRP) | Day 139 |
| C-Reactive Protein (CRP) | Day 186 |
| Alpha-1-acid Glycoprotein (AGP) | Day 0 |
| Alpha-1-acid Glycoprotein (AGP) | Day 46 |
| Alpha-1-acid Glycoprotein (AGP) | Day 93 |
| Alpha-1-acid Glycoprotein (AGP) | Day 139 |
| Alpha-1-acid Glycoprotein (AGP) | Day 186 |
| Intestinal Fatty Acid-binding Protein (I-FABP) | Day 0 |
| Intestinal Fatty Acid-binding Protein (I-FABP) | Day 90 |
| Intestinal Fatty Acid-binding Protein (I-FABP) | Day 183 |
| Calprotectin | Day 0 |
| Calprotectin | Day 90 |
| Calprotectin | Day 183 |
| Hepcidin | Day 0 |
| Hepcidin | Day 46 |
| Hepcidin | Day 90 |
| Hepcidin | Day 139 |
| Hepcidin | Day 183 |
| Event rate of GI side effects | Day 90 |
| Event rate of GI side effects | Day 183 |
| Incidence of GI side effects | Day 90 |
| Incidence of GI side effects | Day 183 |
| Event proportion of GI side effects | Day 90 |
| Event proportion of GI side effects | Day 183 |
| Severity of GI side effects | Day 90 |
| Severity of GI side effects | Day 183 |
| Fecal blood losses | Day 0 |
| Fecal blood losses | Day 90 |
| Fecal blood losses | Day 183 |
| Iron absorption from supplements | Day 90 |
| Iron absorption from supplements | Day 183 |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |