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| Name | Class |
|---|---|
| Swiss Tropical & Public Health Institute | OTHER |
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Intravenous iron preparations have been shown to be superior to oral iron and have largely replaced the treatment of anaemia in Northern countries. However, the socio-economic and medical conditions in low resource countries greatly differ from those in northern countries. Patients' different access to medication supply, perception of medication need and compliance as well as the burden of concomitant disease like malaria, soil-transmitted helminths, schistosomiasis, HIV and red blood cells (RBC) genetic disorders may influence effectiveness and safety of iron substitution modality. The aim of the present study is to compare iv iron substitution by ferric carboxymaltose (Ferinject®) to per oral iron substitution in a low resource country
The objectives of the study are as follows:
Primary objective:
To assess the superiority in terms of effectiveness of iv iron substitution with ferric carboxymaltose versus per oral iron substitution in women with iron deficient anemia at delivery in Tanzania.
Secondary objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV ferric carboxymaltose | Experimental | IV Ferric carboxymaltose is given at a dose calculated according to the severity of anemia and patients weight. The maximal weekly dose is 1000mg. If total dose exceeds 1000mg the dose is split in 1-3 infusions with one infusion per week. |
|
| Ferrous sulphate 60mg+Folic acid 0.25mg | Active Comparator | Three dried ferrous sulphate and folic acid tablets every morning 30 mins before the meal. If side effects occur the drug may be taken with the meal or in 2 separate doses per day. The treatment will be pursued for 3 months after correction of anemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric carboxymaltose | Drug | Intravenous Ferric carboxymaltose given at a calculated dose of 20mg/kg body weight in 1-3 infusions according to severity of anemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of women with correction of hemoglobin to normal values (Hb> 11.5g/dl) at 6 weeks by treatment arm | The proportion of women in each trial arm who have attained the corrected hemoglobin to normal values after starting trial treatment. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Best response (Hemoglobin) in grams per decilitre (g/dl) | Is the highest hemoglobin value or maximal hemoglobin increase after start of study medication | up to 1 year |
| Percentage of women with corrected iron deficiency (Ferritin>50ng/ml) in each arm |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC) | Is the probability that a test (erythrocyte indices) will indicate iron deficiency among participants with the disease as confirmed by iron metabolism parameters (Gold standard). It will be reported as percentage. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandrine Meyer-Monard, PD DrMed | Swiss Tropical & Public Health Institute | Principal Investigator |
| Salim Abdulla, MD,PhD | Ifakara Health Institute | Study Chair |
| Marcel Tanner, PhD, MPH | Swiss Tropical & Public Health Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ifakara Health Institute | Bagamoyo | 74 | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21707575 | Background | van Hensbroek MB, Jonker F, Bates I. Severe acquired anaemia in Africa: new concepts. Br J Haematol. 2011 Sep;154(6):690-5. doi: 10.1111/j.1365-2141.2011.08761.x. Epub 2011 Jun 28. | |
| 21813172 | Background | Balarajan Y, Ramakrishnan U, Ozaltin E, Shankar AH, Subramanian SV. Anaemia in low-income and middle-income countries. Lancet. 2011 Dec 17;378(9809):2123-35. doi: 10.1016/S0140-6736(10)62304-5. Epub 2011 Aug 1. |
| Label | URL |
|---|---|
| Tanzania Food and Drugs Authority | View source |
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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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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| C020748 | ferrous sulfate |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Ferrous sulfate + folic acid | Drug | Three dried ferrous sulfate and folic acid tablets every morning 30 mins before the meal. If side effects occur the drug may be taken with the meal or in 2 separate doses per day. The treatment will be pursued for 3 months after correction of anemia |
|
|
The proportion of women in each trial arm who have attained the corrected serum ferritin levels to normal values after starting trial treatment in nanograms per milliltre(ng/mL)
| 6 weeks |
| Best response (Ferritin) in nanograms per milliltre (ng/mL) | Is the highest ferritin value or maximal ferritin increase after start of study medication. The proportion of women in each trial arm who have attained the corrected serum ferritin levels to normal values after starting trial treatment | up to 1 year |
| Time to response (Hemoglobin) in weeks | Is the time interval between the date of start of study medication until the date of reaching maximal hemoglobin value | up to 1 year |
| Time to response (Ferritin) in weeks | Is the time interval between the date of start of study medication until the date of reaching maximal ferritin value | up to 1 year |
| Response duration (Hemoglobin) in weeks | Is the time from the date when the highest hemoglobin value is reached until the date of decrease to Hb<11.5 g/dl or a decrease of more than 1 g/dl | up to 1 year |
| Response duration (Ferritin) in weeks | Is the time from the date when the highest ferritin value is reached until the date of decrease to ferritin<50 ng/ml | up to 1 year |
| Frequency and severity of solicited and non-solicited adverse events after IV ferric carboxymaltose substitution and oral iron substitution | Number of participants with adverse events either clinical events or abnormal laboratory values with grading of severity reported according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4 | up to 1 year |
| Compliance to study medication intake after intravenous ferric carboxymaltose substitution and oral iron substitution (Questionnaire and pill count) | The proportion of women in each trial arm who have completed the trial related treatment either the number of prescribed infusions of ferric carboxymaltose or oral tablets of ferrous sulphate and folic acid | up to 1 year |
| 1 year |
| Specificity of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania ((parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC) | Is the fraction of those without disease (iron deficiency) confirmed by iron metabolism parameters who will have a negative test (erythrocyte indices) results. It will be reported as percentage. | 1 year |
| Positive predictive value of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC) | Is the proportion of participants who truly have the disease(iron deficiency) as confirmed by iron metabolism parameters among the total number of participants with positive test results(erythrocyte indices). It will be reported as percentage. | 1 year |
| Negative predictive value of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC) | Is the proportion of participants who do not have the disease(iron deficiency) as confirmed by iron metabolism parameters among the total number of participants with negative test results(erythrocyte indices). It will be reported as percentage. | 1 year |
| 11518906 | Background | Bodnar LM, Scanlon KS, Freedman DS, Siega-Riz AM, Cogswell ME. High prevalence of postpartum anemia among low-income women in the United States. Am J Obstet Gynecol. 2001 Aug;185(2):438-43. doi: 10.1067/mob.2001.115996. |
| 20962160 | Background | Zimmermann MB, Chassard C, Rohner F, N'goran EK, Nindjin C, Dostal A, Utzinger J, Ghattas H, Lacroix C, Hurrell RF. The effects of iron fortification on the gut microbiota in African children: a randomized controlled trial in Cote d'Ivoire. Am J Clin Nutr. 2010 Dec;92(6):1406-15. doi: 10.3945/ajcn.110.004564. Epub 2010 Oct 20. |
| 21367937 | Background | Lynch SR. Why nutritional iron deficiency persists as a worldwide problem. J Nutr. 2011 Apr 1;141(4):763S-768S. doi: 10.3945/jn.110.130609. Epub 2011 Mar 2. |
| 17666600 | Background | Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78. doi: 10.1097/01.AOG.0000275286.03283.18. |
| 19682342 | Background | Van Wyck DB, Mangione A, Morrison J, Hadley PE, Jehle JA, Goodnough LT. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion. 2009 Dec;49(12):2719-28. doi: 10.1111/j.1537-2995.2009.02327.x. Epub 2009 Jul 22. |
| 21942989 | Background | Moore RA, Gaskell H, Rose P, Allan J. Meta-analysis of efficacy and safety of intravenous ferric carboxymaltose (Ferinject) from clinical trial reports and published trial data. BMC Blood Disord. 2011 Sep 24;11:4. doi: 10.1186/1471-2326-11-4. |
| 20107144 | Background | Rohner F, Zimmermann MB, Amon RJ, Vounatsou P, Tschannen AB, N'goran EK, Nindjin C, Cacou MC, Te-Bonle MD, Aka H, Sess DE, Utzinger J, Hurrell RF. In a randomized controlled trial of iron fortification, anthelmintic treatment, and intermittent preventive treatment of malaria for anemia control in Ivorian children, only anthelmintic treatment shows modest benefit. J Nutr. 2010 Mar;140(3):635-41. doi: 10.3945/jn.109.114256. Epub 2010 Jan 27. |
| 15671224 | Background | Beard JL, Hendricks MK, Perez EM, Murray-Kolb LE, Berg A, Vernon-Feagans L, Irlam J, Isaacs W, Sive A, Tomlinson M. Maternal iron deficiency anemia affects postpartum emotions and cognition. J Nutr. 2005 Feb;135(2):267-72. doi: 10.1093/jn/135.2.267. |
| 33245866 | Derived | Vanobberghen F, Lweno O, Kuemmerle A, Mwebi KD, Asilia P, Issa A, Simon B, Mswata S, Schmidlin S, Glass TR, Abdulla S, Daubenberger C, Tanner M, Meyer-Monard S. Efficacy and safety of intravenous ferric carboxymaltose compared with oral iron for the treatment of iron deficiency anaemia in women after childbirth in Tanzania: a parallel-group, open-label, randomised controlled phase 3 trial. Lancet Glob Health. 2021 Feb;9(2):e189-e198. doi: 10.1016/S2214-109X(20)30448-4. Epub 2020 Nov 24. |
| Swiss Tropical and Public Health Institute | View source |
| Ifakara Health Institute | View source |
| National Institute for Medical Research | View source |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006571 | Heterocyclic Compounds |